AFFIRM ®

Vertebral Compression Fracture System

SURGICAL TECHNIQUE GUIDE GLOBUSMEDICAL.COM |

 Our mission is to deliver cutting-edge technology,
research, and innovative solutions to promote healing in
patients with musculoskeletal disorders.

The Surgical Technique shown is for illustrative purposes only. The technique(s) actually employed in each case always depends
on the medical judgment of the surgeon exercised before and during surgery as to the best mode of treatment for each patient.
Additionally, as instruments may occasionally be updated, the instruments depicted in this Surgical Technique may not be
exactly the same as the instruments currently available. Please consult with your sales representative or contact Globus directly
for more information.
SURGICAL TECHNIQUE GUIDE

AFFIRM VCF ®

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Product Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Surgical Technique
1. Approach and Instrument Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2. Bone Access. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Option A: Non-Cannulated Access - Premier or Ultra . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Option B: Cannulated Access - Premier Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3. Cement Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Cement Mixer & 3cc Syringe Pack: FORTRESS® Bone Cement . . . . . . . . . . . . . . . . . . . . 18
Cement Mixer & Transfer Pack: FORTRESS® Plus Bone Cement . . . . . . . . . . . . . . . . . . . 19
4. Cavity Creation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Option A: Inflatable Bone Tamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Option B: Expanding Scraper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5. Cement Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
AFFIRM® VCF Ordering Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Important Information on the AFFIRM® VCF System - Instruments . . . . . . . . . . . . . . . . . . . . 31
Important Information on the AFFIRM® VCF System - Inflatable Bone Tamp . . . . . . . . . . .34
Important Information on the FORTRESS® Radiopaque Bone Cement . . . . . . . . . . . . . . . . 36
 AFFIRM ®

Vertebral Compression Fracture System

Every VCF patient is unique. The AFFIRM® VCF System allows VCF treatment to be customized
based on the patient’s specific needs, from bone access through cement delivery. AFFIRM® cannulas
are designed to insert and dock easily, and prevent adjacent level interference. AFFIRM® also features
a fully adjustable cavity creation tool that can create specialized cavities based on vertebral body
size and fracture type.
Designed for both vertebroplasty and vertebral augmentation, AFFIRM® is the only system needed
to treat VCF patients.

4 | AFFIRM® Vertebral Compression Fracture System

 Customized VCF treatment for
every patient, every time.

Custom Cavity Creation

The fully adjustable AFFIRM® Expanding Scraper and variety of Bone Tamps easily create
specialized cavities based on vertebral body size and fracture.

Intelligent Cannula Design

AFFIRM® cannulas feature winged handles for ease of removal and a streamlined approach.

An Array of Treatment Options

Choose from numerous options for access, cavity creation, and cement delivery to create a
unique treatment plan for every patient.

LIFE MOVES US | 5
 PRODUCT SPECIFICATIONS

ACCESS

• Includes Cannulas, Introducers, and Drills

• Ultra (10Ga.)
• Premier (8Ga.)
• Available in packs and singles

Cannula, Ultra
Cannula, Premier

Introducer

Bevel Tip Trocar Tip Quad Tip

(black handle) (white handle) (blue handle)

Biopsy Needle

Drill, Ultra (white handle)

Drill, Premier (blue handle)

6 | AFFIRM® Vertebral Compression Fracture System

 ACCESS (CONT’D)

K-Wire

Round Tip Trocar Tip

Cannula and Cannulated Introducer

Blunt Tip Short Drill Tip

BONE CEMENT

FORTRESS® Bone Cement

• PMMA cement with 28% barium sulfate
• 10 minute dough time and 10–23 minute working period at 23°C
• 20g; yields approximately 12cc of cement

FORTRESS® Plus High Viscosity Bone Cement

• PMMA cement with 28% barium sulfate
• 3 minute dough time and 3–15 minute working period at 23°C
• 20g; yields approximately 12cc of cement

Cement Type Mixing Time Dough Time Working Time*

FORTRESS ®
0-60 seconds 10 minutes 10-23 minutes
FORTRESS Plus ®
0-40 seconds 3 minutes 3-15 minutes
*Times shown indicate total time elapsed.

LIFE MOVES US | 7
 CEMENT MIXING AND DELIVERY

Filler Delivery Needles

• Ultra: Each needle holds 1cc of cement
• Premier: Each needle holds 1.5cc of cement
• Available in packs

FORTRESS® Cement Mixer FORTRESS® Plus Cement Mixer

CAVITY CREATION

Inflatable Bone Tamps

Ultra, 10U Ultra, 15U Premier, 15P Premier, 20P

8 | AFFIRM® Vertebral Compression Fracture System

 CAVITY CREATION (CONT’D)

Inflatable Bone Tamps, Ultra – for 3.4mm Diameter Working Channel

10U 15U
Maximum Inflation Volume 4cc ±0.4 cc 5cc ±0.4 cc
Maximum Inflation Pressure 400psi 400psi
Nominal Inflated Diameter 16mm 16mm
Nominal Inflated Length 20mm 28mm

Inflatable Bone Tamps, Premier – for 4.2mm Diameter Working Channel

15P 20P
Maximum Inflation Volume 4cc ±0.4 cc 6cc ±0.4 cc
Maximum Inflation Pressure 400psi 400psi
Nominal Inflated Diameter 16mm 17mm
Nominal Inflated Length 22mm 30mm

Expanding Scraper
• Works with both Ultra and Premier instruments
• 16mm maximum cutting diameter
• Stainless steel sheath
• Nitinol tip

AFFIRM® Inflation Device with VacLok® Syringe

LIFE MOVES US | 9
 SURGICAL TECHNIQUE

AFFIRM VCF System ®

STEP 1 APPROACH AND INSTRUMENT SELECTION

Place the patient under local or general anesthesia in a prone position. Carefully clean the operative area and use a scalpel to
make an incision at the appropriate vertebral level(s). If planning height restoration, find the closest normal vertebral bodies
above and below the treatment area and note their heights for reference.
Using the patient’s anatomy as a guide, select the appropriate AFFIRM® instruments to be used — Premier (8Ga.) or Ultra
(10Ga.).
Note: Height restoration may not be achieved in chronic fractures.1

Patient Positioning

1. C
 randall D, Slaughter D, Hankins PJ, Moore C, Jerman J. Acute versus chronic vertebral compression fractures treated with kyphoplasty: early results.
Spine Journal. 2004 Jul-Aug; 4(4):418-424.

10 | AFFIRM® Vertebral Compression Fracture System

 STEP 2 BONE ACCESS
There are two possible approaches for bone access: transpedicular and extrapedicular. This surgical technique guide describes
a transpedicular approach.

OPTION A: Non-Cannulated Access - Premier or Ultra

Insert an Introducer through its corresponding Cannula and advance both instruments through the soft tissue into the
pedicle of the selected vertebra. Use fluoroscopic guidance to confirm that the tips of the Cannula and Introducer are
positioned just past the pedicle and inside the vertebral body. Repeat on the contralateral side.
Repeat these steps and use additional cannulae as needed for multiple levels.

Introducer

Cannula

Inserting Introducer - Axial View

Inserting Introducer - Sagittal View

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 BONE ACCESS (CONT’D)
Remove the Introducer from the Cannula by rotating it counterclockwise and pulling upward, leaving the Cannula in the
vertebra. If desired, perform biopsy collection at this point in the procedure (below right).

OPTIONAL: BIOPSY COLLECTION

Separate the Obturator from the Biopsy Needle.
Insert the needle through the Cannula into
the vertebra under fluoroscopic guidance and
rotate the handle clockwise for tissue collection.
Remove the needle once tissue collection is
complete. Push the Obturator through the needle
to expel the tissue sample from the needle.

Obturator

Biopsy Needle

Removing Introducer

12 | AFFIRM® Vertebral Compression Fracture System

Insert the Drill through the Cannula and twist continuously in a clockwise direction under fluoroscopic guidance to create
an access channel. Stop drilling prior to reaching the anterior wall. If necessary, the Drill can be repositioned by backing
out and reinserting at a different angle. Once the length and trajectory of the channel are acceptable, remove the Drill from
the Cannula.

Drill

Drilling Channel - Axial View

Cannula

Drilling Channel - Sagittal View

LIFE MOVES US | 13
 BONE ACCESS (CONT’D)
OPTION B: Cannulated Access - Premier Only
Insert a Jamshidi Needle, Bevel Tip, Premier through the soft tissue into the pedicle of the selected vertebra. Use
fluoroscopic guidance to confirm that the tip of the needle has moved just past the pedicle into the vertebral body. Upon
reaching the desired depth, remove the needle from the Jamshidi Cannula by rotating the black handle and pulling upwards.
Place a K-Wire through the Jamshidi Cannula into the vertebra using fluoroscopic guidance.

Needle

Inserting Jamshidi Needle - Axial View

Cannula

Inserting Jamshidi Needle - Sagittal View

14 | AFFIRM® Vertebral Compression Fracture System

Remove the Jamshidi Cannula and place the assembled Introducer, Cannulated, Premier and Cannula, Premier over the
K-Wire. Rotate the introducer handle clockwise to advance further into the vertebra using fluoroscopic guidance. Upon
reaching the desired depth, remove the introducer and the K-Wire. Repeat on the contralateral side.
Repeat these steps and use additional cannulas as needed for multiple levels.

K-Wire

Introducer, Cannulated Drill Tip

Cannula, Premier

LIFE MOVES US | 15
 BONE ACCESS (CONT’D)
Insert the Drill, Premier through the cannula and rotate continuously in a clockwise direction under fluoroscopic guidance
to advance the access channel. Stop prior to reaching the anterior wall. If necessary, the drill can be repositioned by backing
out and reinserting at a different angle. Once the length and trajectory of the channel are acceptable, remove the drill from
the cannula.

Drill, Premier

Drilling Channel - Axial View

Cannula, Premier

Drilling Channel - Sagittal View

16 | AFFIRM® Vertebral Compression Fracture System

 STEP 3 CEMENT PREPARATION
The scrub technician may begin preparing the cement while the surgeon proceeds to cavity creation. This allows time for the
cement to dough while the cavity is being created.

Monomer Polymer

Mix the monomer and polymer together in the Cement Mixer.

Mixing Times
FORTRESS® 60 seconds
FORTRESS Plus
®
40 seconds

Immediately after mixing, using a syringe, extract the cement from the mixer and insert it into the filler Delivery Device. Be
sure to allow for the appropriate dough time.

Dough Time*
FORTRESS® 10 minutes
FORTRESS Plus
®
3 minutes
*Dough times can vary based on the temperature in the room.
*Dough times begin as soon as the monomer and polymer make contact.

LIFE MOVES US | 17
 CEMENT PREPARATION (CONT’D)
FORTRESS® bone cement uses the Cement Mixer and 3cc Syringe Pack while FORTRESS® Plus uses the Cement Mixer and
Transfer Pack. The handling characteristics and setting time of the cement may vary with temperature, mixing technique, and
humidity. Refer to the graphs and table in the FORTRESS® product insert.

CEMENT MIXER AND 3cc SYRINGE PACK

for use with FORTRESS® Bone Cement

Pour the powder followed by the liquid into  Attach a 3cc syringe to the mixer port. Thread
1 2 the mixer base clockwise until the blue line
the cement mixer and mix for 60 seconds.
Do not hold the clear portion of the cylinder is below the luer lock of the syringe. Aspirate
when mixing. cement into the syringe. Thread the mixer base
counterclockwise until the blue line is above the
luer lock to remove the syringe.

DO NOT
hold here

Hold here

Cement Transfer
3
• Connect a filler delivery needle to the syringe and push the plunger to fill the needle with cement
•E
 xpel 1cm of cement from the end of the filler needle (“dry plug”)
• Continue filling remaining needles
• Use the filler plungers for cement injection through the cannula

18 | AFFIRM® Vertebral Compression Fracture System

 CEMENT MIXER AND TRANSFER PACK
for use with FORTRESS® Plus Bone Cement

1 2 3 4

Remove the threaded luer cap Pour the powder, then Remove the lid and insert Turn the mixer horizontal with
from the syringe. liquid into the cement the threaded plunger. the port facing up. Thread
mixer and mix for 40 the mixer base clockwise
Rotate the threaded plunger
seconds. Be sure not to until the blue line is below
clockwise until it reaches the
hold the clear portion of the luer lock of the syringe.
cement.
the cylinder. Continue advancing the
Note: Plunger usage may not be threaded plunger to remove all
necessary.
remaining air.

DO NOT
hold here

Hold here

5 6 7
Insert the syringe into the Thread the mixer base Cement Transfer
mixer and load with cement counterclockwise until the
• Connect a filler delivery needle to the syringe and push
by continuing to advance blue line is above the luer lock.
the plunger to fill the needle with cement
the threaded plunger. With
Remove the syringe while
the syringe attached to the • Expel 1cm of cement from the end of the filler needle
holding it vertically and re-
mixer, the port can also face (“dry plug”)
attach the threaded luer cap.
downward for more effective • Continue filling remaining needles
filling. Note: When the white tabs are
pulled proximally towards the clear • Use the filler plungers for cement injection through the
tabs of the syringe, the clear tabs
cannula
engage the threads on the plunger.
Once engaged the syringe cannot
be refilled.

Note: Do not fill the syringe beyond the

10ml marking. LIFE MOVES US | 19
 CEMENT PREPARATION (CONT’D)
Checking Bone Cement Viscosity
FORTRESS® Bone Cement: Begin checking viscosity approximately eight minutes after the powder and liquid components
contact one another.
FORTRESS® Plus Bone Cement: Begin checking viscosity approximately two minutes after the powder and liquid
components contact one another.
To check viscosity extrude a small amount of bone cement from the tip of each filler needle onto two fingers by inserting the
filler needle plunger in the filler needle cannula. If the bone cement pulls fibers, it is not ready and should stand for more time.
The cement should stick to one finger when compressed into a ball once it has reached dough time.
Note: Dough time should be measured beginning from the moment of initial contact between the liquid and powder,
not from the loading of the filler needle. Variations in temperature, working environment, product, and accessories may
decrease or increase dough time.

NOT READY

READY

20 | AFFIRM® Vertebral Compression Fracture System

 STEP 4 CAVITY CREATION
Option A: Inflatable Bone Tamp
Select an appropriately sized Inflatable Bone Tamp. Use the Inflation Device with VacLok® Syringe to prepare the Inflatable
Bone Tamp as follows:
Remove the red tab from the inflation device, turn on the pressure gauge (green button) and change the display from ATM to
psi units (blue button).

Blue: ATM/psi

Green: On/Off

Fill the inflation device with a 50:50 contrast medium/saline solution mixture. Align the inflation device plunger with the zero
on the barrel and remove all air bubbles from inside the barrel and the tubing.

“0”

LIFE MOVES US | 21
 CAVITY CREATION (CONT’D)
While keeping the bone tamp protector in place, tighten the stylet into the bone tamp and confirm that it is locked in place.

Push the VacLok® Syringe plunger fully into the barrel. Attach the VacLok® Syringe to the open port on the bone tamp, then
pull the VacLok® Syringe plunger back and rotate it clockwise to lock the vacuum. Repeat this step as needed to remove all air
from the bone tamp.

Once all air is removed from the bone tamp, remove the VacLok® Syringe and attach the inflation device to the vacated port.
The bone tamp protector may now be removed.

22 | AFFIRM® Vertebral Compression Fracture System

Place the bone tamp through the Cannula into the vertebra and advance it to the desired depth under fluoroscopic guidance.
Verify the position before inflating the bone tamp.

Inflation Device

Inflatable Bone Tamp

Cannula

LIFE MOVES US | 23
 CAVITY CREATION (CONT’D)
Verify the location of the bone tamp by identifying the radiopaque markers at both ends of the balloon under fluoroscopy.
Slowly inflate the bone tamp. Take A/P and lateral fluoroscopy images every 0.5ml to confirm progress until achieving the
desired inflation volume. Inflate no more than the maximum volume of the selected balloon.
Note: Be careful not to perforate any cortical bone surfaces.

Radiopaque markers

Appearance under fluoroscopy — uninflated Appearance under fluoroscopy — inflated

After safely achieving the desired balloon inflation, leave the bone tamp inflated for 3-5 minutes to help slow any
intracancellous bleeding.
When ready, deflate the bone tamp by compressing the handle of the inflation device and pulling it all the way back.
Remove the bone tamp from the vertebra by slowly pulling it back through the Cannula under fluoroscopic guidance.

INFLATING THE INFLATABLE BONE TAMP

When using the inflation device to inflate the bone tamp, each 360°
clockwise rotation of the inflation device handle will deliver approximately
0.5cc of fluid to the balloon.

Ultra Maximum Inflation Volume

10U 4cc ±0.4 cc
15U 5cc ±0.4 cc

Premier Maximum Inflation Volume

10P 4cc ±0.4 cc
15P 4cc ±0.4 cc

24 | AFFIRM® Vertebral Compression Fracture System

Option B: Expanding Scraper
Use the Expanding Scraper when the pressure of an inflatable bone tamp
yields a pressure greater than 150 psi or if the bone tamp approaches the
borders of the vertebral body. The scraper redirects the cavity towards the
center of the vertebral body.
To use the scraper, retract the tip of the scraper by holding the T-handle
stationary and rotating the black knob clockwise.
Insert the Expanding Scraper through the Cannula and advance it to the
desired depth under fluoroscopic guidance. Holding the T-handle stationary,
slowly rotate the black knob counterclockwise to control the expansion and
clockwise retraction of the scraper tip inside the vertebral body, expanding
the cutting tip incrementally.
Using fluoroscopic guidance, create a suitable cavity for cement injection.
Do not advance if there is substantial resistance within the bone. If
resistance is felt, reduce the radius of the cutting tip by adjusting the black
knob and create the cavity.
After creating the desired cavity, slowly rotate the black knob on the
T-handle clockwise until it stops to retract the scraper tip. Carefully pull the
scraper out of the cannula under fluoroscopic guidance.

Black knob

T-Handle

Rotating black knob to control Expanding

Scraper tip

LIFE MOVES US | 25
 STEP 5 CEMENT DELIVERY
Prepare the Bone Cement by mixing together the liquid and powder components according to the Bone Cement Instructions
For Use (Step 3). If desired, Cement may be mixed using the Cement Mixer as per the Cement Mixer Instructions for Use.

Loading syringe with bone cement

Optional: Cement Needle Plunger

Separate the Needle Plungers from the Filler Delivery

Filler Delivery Needle
Needles and load with cement using a 3cc syringe.
Ensure that all air is expelled by allowing a few drops
of cement to drip from the tip of the needle. Repeat
Cannula
this step to load multiple needles with cement.
See Step 3 for more detailed instructions. Advance
the needle through the Cannula to the desired depth
under fluoroscopic guidance. Use the O-Ring to keep
the needle in place.
O-Ring

26 | AFFIRM® Vertebral Compression Fracture System

Deliver Bone Cement into the vertebra under fluoroscopic guidance using the Needle Plunger. Once the desired amount
of cement has been injected, leave the last Filler Delivery Needle and plunger in place while the cement is curing and
periodically rotate the instrument in order to keep it from adhering to the cement. Allow the bone cement to fully cure. Refer
to the important information on FORTRESS® Radiopaque Bone Cement for guidance on adequate curing time.
After confirming that the cement is fully cured, remove the needle and the Cannula under fluoroscopic guidance.

LIFE MOVES US | 27
 AFFIRM® VCF SYSTEM
ORDERING GUIDE
The AFFIRM® VCF System creates a unique treatment plan for every patient, every time.
Ideal for both vertebroplasty and kyphoplasty, AFFIRM® offers numerous options for access, cavity creation, and cement
delivery. AFFIRM®’s modular packaging can help control costs by minimizing wasted instruments.
Items are available in procedural kits and individual component packs. Simply choose the kit and/or components needed for
each unique case to customize treatment and minimize costs.

ONE LEVEL TWO LEVEL

• (1) VCF Kit • (1) VCF Kit
• FORTRESS Bone Cement
®
• (1) Bone Tamp Pack
• Cement Mixer • (1) Filler Deliver Pack
• (1) Cannula Pack
A La Carte
• Cement Mixer
• FORTRESS® Bone Cement
• FORTRESS® Bone Cement
• Cement Mixer
• (1) Access Pack A La Carte

• (1) Filler Delivery Device Pack • FORTRESS® Bone Cement

• (1) Inflatable Bone Tamp Pack • Cement Mixer

• (1) Inflation Device • (1) Access Pack

• (1) Cannula Pack
• (1) Filler Delivery Device Pack
• (2) Inflatable Bone Tamp Pack
• (2) Inflation Device

INDEPENDENCE
28 | AFFIRM®
VertebralMIS
Compression
™
Fracture System
AFFIRM® VCF SYSTEM
ORDERING GUIDE
Bone Cement and Mixing Tapered:

FORTRESS®: 658.935S Ultra, Tapered, 10U

658.936S Ultra, Tapered, 15U
4129.2000S FORTRESS® Radiopaque Bone Cement, 20g
Includes: Cannula (2)
658.969S Cement Mixer and 3cc Syringe Pack
Cannula Introducer, Bevel Tip (1)
Includes: Standard viscosity cement mixer Cannula introducer, Quad Tip (1)
with crank Drill (1)
3cc Polypropylene syringes (qty. 4) Filler Delivery Needle (8)
Inflation Device (2)
FORTRESS Plus:
® Inflatable Bone Tamp (2)

4129.2020S FORTRESS® Plus Bone Cement, 20g

658.959S Cement Mixer and Transfer Pack Additional Level Kits:
Includes: High viscosity cement mixer with
crank and plunger Premier:
10cc Transfer Syringe 658.927S Premier, 15P
658.928S Premier, 20P
Includes: Cannula (2)
VCF Kits Filler Delivery Needle (6)
Inflatable Bone Tamp (2)
Premier:
Ultra:
658.921S Premier, 15P
658.929S Ultra, 10U
658.922S Premier, 20P
658.930S Ultra, 15U
Includes: Cannula (2)
Cannula Introducer, Trocar Tip (1) Includes: Cannula (2)
Cannula Introducer, Quad Tip (1) Filler Delivery Needle (8)
Drill (1) Inflatable Bone Tamp (2)
Filler Delivery Needle (6) Tapered:
Inflation Device (2) 658.939S Ultra, Tapered, 15U
Inflatable Bone Tamp (2)
Includes: Cannula (2)
Ultra: Filler Delivery Needle (8)
658.923S Ultra, 10U Inflatable Bone Tamp (2)

658.924S Ultra, 15U

Includes: Cannula (2) Access Packs:
Cannula Introducer, Bevel Tip (1) Premier:
Cannula Introducer, Quad Tip (1)
Drill (1) 658.901S Access Pack
Filler Delivery Needle (8) Includes: Cannula (2)
Inflation Device (2) Cannula Introducer, Quad Tip (1)
Inflatable Bone Tamp (2) Cannula Introducer, Trocar Tip (1)
Drill (1)

LIFE MOVES US | 29
 AFFIRM® VCF SYSTEM
ORDERING GUIDE
Ultra: Directional:
658.902S Access Pack 658.539S Premier
Includes: Cannula (2) 658.540S Ultra
Cannula Introducer, Quad Tip (1)
Includes: Filler Delivery Needle (1)
Cannula Introducer, Bevel Tip (1)
Drill (1) Tapered:
658.520S Ultra
Individual Jamshidis Includes: Filler Delivery Needle (1)

Bevel Tip: 658.915S Ultra

Includes: Filler Delivery Needle (8)
658.070S Bevel Tip, 10Ga
658.071S Bevel Tip, 11Ga
658.073S Bevel Tip, 13Ga Premier Components
Includes: Cannula (1) 658.935S AFFIRM® Cannula, Premier (1)
Introducer, Bevel Tip (1)
658.502S AFFIRM® Cannula & Introducer, Trocar Tip, Premier (1)
Quad Tip: 658.503S AFFIRM® Cannula & Introducer, Bevel Tip, Premier (1)
658.080S Quad Tip, 10Ga 658.507S AFFIRM® Drill, Premier (1)
658.081S Quad Tip, 11Ga 658.509S AFFIRM® Filler Delivery Device, Premier (1)
658.083S Quad Tip, 13Ga 658.511S AFFIRM® Cannula & Introducer, Quad Tip, Premier (1)
Includes: Cannula (1) 658.522S AFFRIM® Inflatable Bone Tamp, Premier, 15P (1)
Introducer, Quad Tip (1) 658.523S AFFIRM® Inflatable Bone Tamp Premier, 20P (1)
Biopsy Needles: 658.903S AFFIRM® Cannulated Access Pack, Premier

658.114S Ultra Ultra Components

658.116S Premier
658.504S AFFIRM® Cannula, Ultra (1)
658.583S 13Ga
658.505S AFFIRM® Cannula, & Introducer, Trocar Tip, Ultra (1)
658.585S 15Ga
658.506S AFFIRM® Cannula, & Introducer, Bevel Tip, Ultra (1)
Includes: Biopsy Cannula (1)
658.508S AFFIRM® Drill, Ultra (1)
Biopsy Plunger (1)
658.510S AFFIRM® Filler Delivery Device, Ultra (1)
658.512S AFFIRM® Cannula & Introducer, Quad Tip, Ultra (1)
Filler Delivery Devices 658.524S AFFIRM® Inflatable Bone Tamp, Ultra 10U (1)
658.525S AFFIRM® Inflatable Bone Tamp, Ultra, 15U (1)
Standard:
658.601S Premier Miscellaneous
Includes: Filler Delivery Needle (6) 658.216S AFFRIM® Expanding Scraper (1)
658.914S Ultra 658.909S AFFIRM® Inflation Device (1)
Includes: Filler Delivery Needle (8)

30 | AFFIRM® Vertebral Compression Fracture System

 IMPORTANT INFORMATION ON THE AFFIRM® VCF SYSTEM – INSTRUMENTS
DESCRIPTION • Discitis;
The AFFIRM® VCF System instruments are instrument kits or packs which • Uncorrectable coagulopathy;
consist of: access instruments (including drills, cannulas. jamshidi needles,
and K-wires), biopsy needle, cavity preparation instruments (expanding • Symptomatic cord compression at the level of fracture;
scraper), sleeve, an inflation device, and cement delivery instruments
• Severe cardiopulmonary disease; and
(cement mixer, cement guns, and filler delivery needles).
• Pregnancy
The AFFIRM® VCF System instruments are fabricated from stainless steel and
nitinol as specified in ASTM F899 and ASTM 2063, and from polyurethane. These instruments should not be used if the vertebral body, hand, tibia, radius
or calcaneus dimensions or fracture pattern do not allow safe placement.
INDICATIONS
The AFFIRM® VCF System is intended to be used for the reduction and CONTACT INFORMATION
fixation of fractures and/or creation of a void in cancellous bone in the Globus Medical may be contacted at 1-855-639-6612. A surgical technique
spine, hand, tibia, radius, and calcaneus. This includes percutaneous manual may be obtained by contacting Globus Medical.
vertebral augmentation. Vertebral compression fractures may result from
osteoporosis, benign lesions and/or malignant lesions such as metastatic DIRECTIONS FOR USE – ACCESS TRAY OR PACK (PREMIER AND ULTRA)
cancer and myeloma. The system is to be used with cleared spinal 1. Select appropriate access instrument(s).
polymethylmethacrylate (PMMA) bone cements indicated for use during 2. Make an incision on the skin over the selected vertebra using a scalpel.
percutaneous vertebral augmentation, such as kyphoplasty.
3. Advance a Cannula and Introducer through the soft tissue into the selected
WARNINGS vertebra using alternating AP and lateral fluoroscopy as guidance.
One of the potential risks identified with this system is death. Other potential
risks which may require additional surgery include: 4. Remove the Introducer from the Cannula.

• Embolism of fat, thrombus or other materials resulting in symptomatic 5. Insert the Drill through the Cannula into the bone to advance the access
pulmonary embolism or other clinical sequelae; channel.

• Rupture with fragmentation of the inflatable portion of the IBT resulting in 6. Drill cautiously with image guidance to the required depth.
retention of a fragment within the vertebral body; 7. Remove the Drill once the required depth is reached.
• Rupture of the IBT causing contrast medium exposure, possibility resulting For additional level(s), use Cannulae from the AFFIRM® Cannula Pack.
in an allergic reaction or anaphylaxis;
AFFIRM® ACCESS TRAY OR PACK, PREMIER (4.2MM DIAMETER)
• For a transpedicular approach, if the pedicle is not large enough or stable
enough to withstand the procedure, pedicle fracture may occur;
• Complications that may occur during a parapedicular approach include
pneumothorax and bleeding;
• Do not use this product after the expiration date printed on the package. The Introducer, Bevel Tip (1) Cannula (1)
device may not be safe or effective beyond its expiration date;
Cannula and Introducer, Bevel Tip
• Deep or superficial wound infection;
• Retropathy, paresis or paralysis; and
• Bleeding or hematoma
Certain degenerative diseases or underlying physiological conditions such Introducer, Quad Tip (1) Cannula (1)
as diabetes or rheumatoid arthritis may alter the healing process, thereby
increasing the risk of spinal fracture. Cannula and Introducer, Quad Tip

PRECAUTIONS
The implantation of the AFFIRM® VCF System should be performed only by
experienced spinal surgeons with specific training in the use of this system
due to a risk of serious injury to the patient. Preoperative planning and
Drill Premier (1)
patient anatomy should be considered prior to performing kyphoplasty.
Adequately instruct the patient. Mental or physical impairment which
compromises or prevents a patient’s ability to comply with necessary
limitations or precautions may place that patient at a particular risk during
postoperative rehabilitation.
CONTRAINDICATIONS AFFIRM® ACCESS TRAY OR PACK, ULTRA (3.4MM DIAMETER)
Use of the AFFIRM® VCF System is contraindicated in patients with the
following conditions:
• Active systemic infection, infection localized to the site of the proposed
implantation, or when the patient has demonstrated allergy or foreign body
sensitivity to any of the implant materials;
Introducer, Bevel Tip (1) Cannula (1)
• Patients whose activity, mental capacity, mental illness, alcoholism, drug
abuse, occupation, or lifestyle may interfere with their ability to follow Cannula and Introducer, Bevel Tip
postoperative restrictions and who may place undue stresses on the
Kyphoplasty procedure during healing and may be at a higher risk of failure;
• Bleeding disorder or treatment that increases the chance of excessive
bleeding;
Introducer, Quad Tip (1) Cannula (1)
• Any known severe allergy to contrast material;
• Instability of posterior wall and/or pedicles; Cannula and Introducer, Quad Tip

• Pedicle fracture;
• Epidural abscess;
• Sepsis; Drill Ultra (1)

• Osteomyelitis;
• Active infection;

LIFE MOVES US | 31
 IMPORTANT INFORMATION ON THE AFFIRM® VCF SYSTEM – INSTRUMENTS
DIRECTIONS FOR USE – CANNULATED ACCESS TRAY OR PACK (PREMIER DIRECTIONS FOR USE – BIOPSY NEEDLE
ONLY) 1. Use the existing access channel for biopsy collection.
1. Make an incision on the skin over the selected vertebra using a scalpel.
2. Remove the Obturator from the Biopsy Needle.
2. Place the Jamshidi Needle and Jamshidi Cannula through the soft tissue
into the selected vertebra, using alternating AP and lateral fluoroscopy as 3. Insert the Biopsy Needle through the access cannula into the vertebra using
guidance. fluoroscopic guidance.

3. Remove the Jamshidi Needle from the Jamshidi Cannula. 4. Rotate the handle of the Biopsy Needle for biopsy collection.

4. Place a K-Wire through the Jamshidi Cannula into the bone with image 5. Remove the Biopsy Needle once biopsy collection is completed.
guidance. Remove the Jamshidi Cannula and leave the K-Wire in the bone. 6. Place the Obturator through the Biopsy Needle for biopsy collection.
5. Place the Cannulated Introducer and Cannula over the K-Wire and
advance the Cannulated Introducer and Cannula into the vertebra under
fluoroscopy, then remove the K-Wire.
Obturator (1) Biospy Needle (1)
6. Remove the Cannulated Introducer from the Cannula.
Biopsy Needle
7. Insert the Drill through the Cannula into the bone to advance the access
channel. DIRECTIONS FOR USE – EXPANDING SCRAPER
8. Drill cautiously with image guidance to required depth. 1. Use the existing access channel for cavity preparation.
9. Remove the Drill once the required depth is reached. 2. Insert the Expanding Scraper through the access cannula into the vertebra.
For additional level(s), use Cannulae from the AFFIRM Cannula Pack. ® 3. Advance the Expanding Scraper into the bone using fluoroscopy to ensure
correct placement of the Expanding Scraper.
CANNULATED ACCESS TRAY OR PACK (4.2MM DIAMETER)
4. Rotate the knob on the Expanding Scraper counterclockwise to extend the
scraper tip into contact with bone under fluoroscopic guidance.
5. Actuate the scraper to prepare the cavity using fluoroscopic guidance.
Adjust the angle as necessary.

Jamshidi Cannula, Bevel Tip (1) Jamshidi Needle (1) 6. Rotate the knob on the Expanding Scraper clockwise to retract the scraper
tip under fluoroscopy. When the scraper tip is completely retracted, remove
the Expanding Scraper.
Jamshidi Cannula and Jamshidi Needle, Bevel Tip

Expanding Scraper (1)

Jamshidi Cannula, Quad Tip (1) Jamshidi Needle, Premier (1)

DIRECTIONS FOR USE – SLEEVE
1. If additional reinforcement is desired for the Inflatable Bone Tamp, the
Jamshidi Cannula and Jamshidi Needle, Quad Tip Sleeve may be placed over the Inflatable Bone Tamp, prior to inserting into
the access channel.
2. Continue to follow instructions for insertion and inflation of the Inflatable
Bone Tamp.
3. Remove the Inflatable Bone Tamp and Sleeve prior to injecting cement into
the cavity.
K-Wire, Trocar Tip (2)

Sleeve (1)

K-Wire, Round Tip (2) DIRECTIONS FOR USE – FILLER DELIVERY TRAY OR PACK
1. Use existing access channels for delivery of bone cement to the prepared
cavity.
2. Prepare bone cement in the Cement Mixer according to the mixer
manufacturer’s instructions and the bone cement manufacturer’s
instructions.
3. Separate the Filler Plunger from the Filler Cannula.
Cannulated Introducer, Short Drill Tip (1) Cannula (1) 4. Attach the Filler Cannula to the Mixer and fill with bone cement.
Cannula and Cannulated Introducer, Short Drill Tip 5. Detach the Filler Cannula from the Mixer.
6. To fill multiple Filler Cannulas, repeat steps 1 through 5.
7. Place the Filler Cannula through the Cannula into the vertebra and advance
the Filler Cannula to the intended location under image guidance.
Cannulated Introducer, Blunt Tip (1) Cannula (1)
8. Deliver cement to the intended location of the vertebra by placing the
Cannula and Cannulated Introducer, Blunt Tip Filler Plunger through the Filler Cannula under continuous fluoroscopic
guidance.

Drill, Premier (1)

Filler Plunger, Premier (6) Filler Cannula, Premier (6)

Filler Delivery Needle, Premier

OR

Filler Plunger, Ultra (8) Filler Cannula, Ultra (8)

Filler Delivery Needle, Ultra

32 | AFFIRM Vertebral Compression Fracture System
®
 IMPORTANT INFORMATION ON THE AFFIRM® VCF SYSTEM – INSTRUMENTS
DIRECTIONS FOR USE – EXTENSION DELIVERY PACK
1. Use the existing access channel for delivery of bone cement into the
prepared cavity. Extension Tube (1)

2. Prepare bone cement in the Cement Mixer according to the mixer

manufacturer’s instructions and the bone cement manufacturer’s
instructions.
3. Attach the Syringe to the Cement Mixer.
4. Transfer bone cement to the Syringe.
5. Detach the Syringe from the Cement Mixer. Point the Syringe upward;
rotate the plunger to inject cement into the distal end of the Disposable
Syringe to remove air.
Cement Gun with Syringe (1)
6. Load the Syringe in the Cement Gun.
7. Connect the fixed end of the Extension Tube to the Syringe.
8. Separate the Needle Plunger from the Filler Delivery Needle. STERILIZATION
9. Connect the rotating end of the Extension Tube to the luer port of the Filler The AFFIRM® instruments and Cement Mixer are sterilized by gamma
Delivery Needle. radiation using a standard medical device sterilization dose of 25-40kGy. This
dose was validated using the VDMAX method according to ANSI/AAMI/ISO
10. Purge air from the Syringe and the Filler Delivery Needle by rotating 11137-2:2006 Sterilization of Healthcare Products. Sterilization validation was
the plunger of the Syringe to inject cement to the distal end of the Filler performed to ensure a sterility assurance level (SAL) of 10-6.
Delivery Needle.
The Inflation Device is sterilized using Ethylene Oxide (EtO) and meets the
11. Place the Filler Delivery Needle through the access cannula into the requirements of ANSI/AAMI/ISO 11135:1994 Medical Devices – Validation
vertebra and advance the Filler Delivery Needle to the intended location and Routine Control of Ethylene Oxide Sterilization. Sterilization validation
under fluoroscopic guidance. was performed to ensure a sterility assurance level (SAL) of 10-6.
12. Deliver cement to the intended location of the vertebra by rotating the Some AFFIRM® instruments are provided NONSTERILE. Sterilization is
plunger of the Syringe under continuous fluoroscopic guidance. recommended as follows:
13. Once cement delivery is completed, remove the Extension Tube and Filler Method Cycle Type Temperature Exposure Time Drying Time
Delivery Needle under fluoroscopy.
Steam Pre-vacuum 132°C (270°F) 25 Minutes 45 Minutes

Pre-vacuum
(wrapped)
Steam 132°C (270°F) 15 Minutes 30 Minutes
Extension Tube (1) Pre-conditioning
pulses: 3

STORAGE
The AFFIRM® instruments should be stored in their original shipping
Syringe (1)
materials. Proper care should be taken to ensure that the instruments are not
damaged. Store the instruments in a cool, dry place.
CAUTION: Federal (USA) Law Restricts this Device to Sale by or on the order
of a Physician.
DIRECTIONS FOR USE – CEMENT INJECTION PACK
1. Use the existing access channel for delivery of bone cement into the
prepared cavity. SYMBOL TRANSLATION

2. Prepare bone cement in the Cement Mixer according to the mixer

CATALOGUE NUMBER STERILIZED BY IRRADIATION
manufacturer’s instructions and the bone cement manufacturer’s
instructions.
AUTHORISED
3. Attach the Cement Gun with Syringe to the Cement Mixer. LOT NUMBER REPRESENTATIVE IN THE
EUROPEAN COMMUNITY
4. Transfer bone cement to the Cement Gun.
5. Detach the Cement Gun from the Cement Mixer. Point the gun upward; CAUTION MANUFACTURER
rotate plunger to inject cement into the distal end of the syringe to remove
air.
SINGLE USE ONLY Use by (YYYY-MM-DD)
6. Connect the fixed end of the Extension Tube to the Cement Gun.
7. Separate the Needle Plunger from the Filler Delivery Needle.
QUANTITY
8. Connect the rotating end of the Extension Tube to the luer port of the Filler
Delivery Needle.
9. Purge air from the Cement Gun and the Filler Delivery Needle by rotating DI148A REV C
the plunger of the Syringe to inject cement to the distal end of the Filler
Delivery Needle.
10. Place the Filler Delivery Needle through the access cannula into the
vertebra and advance the Filler Delivery Needle to the intended location
under fluoroscopic guidance.
11. Deliver bone cement to the intended location of the vertebra by rotating
the plunger of the Syringe under continuous fluoroscopic guidance.
12. Once cement delivery is completed, remove the Extension Tube and Filler
Delivery Needle under fluoroscopy.

LIFE MOVES US | 33
 IMPORTANT INFORMATION ON AFFIRM® VCF SYSTEM – INFLATABLE BONE TAMP
DESCRIPTION • The inflation characteristics of the Inflatable Bone Tamp are altered by
The AFFIRM® Inflatable Bone Tamp is a bone tamp with an inflatable inflation inside the bone.
balloon attached to the distal end, designed to create a void in cancellous CONTRAINDICATIONS
bone. The Inflatable Bone Tamp is a sterile, single-use device manufactured
from polyurethane. The AFFIRM® Curved Bone Tamp is the same AFFIRM® Use of the AFFIRM® VCF System is contraindicated in patients with the
following conditions:
Inflatable Bone Tamp with a curved introduction sleeve.
• Active systemic infection, infection localized to the site of the proposed
INDICATIONS
implantation, or when the patient has demonstrated allergy or foreign body
The AFFIRM® VCF System is intended to be used for the reduction and sensitivity to any of the implant materials;
fixation of fractures and/or creation of a void in cancellous bone in the
spine, hand, tibia, radius, and calcaneus. This includes percutaneous • Patients whose activity, mental capacity, mental illness, alcoholism, drug
vertebral augmentation. Vertebral compression fractures may result from abuse, occupation, or lifestyle may interfere with their ability to follow
osteoporosis, benign lesions and/or malignant lesions such as metastatic postoperative restrictions and who may place undue stresses on the
cancer and myeloma. The system is to be used with cleared spinal Kyphoplasty procedure during healing and may be at a higher risk of failure;
polymethylmethacrylate (PMMA) bone cements indicated for use during
• Bleeding disorder or treatment that increases the chance of excessive
percutaneous vertebral augmentation, such as kyphoplasty.
bleeding;
WARNINGS
• Any known severe allergy to contrast material or bone cement;
One of the potential risks identified with this system is death. Other potential
risks which may require additional surgery include: • Instability of posterior wall and/or pedicles;
• Embolism of fat, thrombus or other materials resulting in symptomatic • Pedicle fracture,
pulmonary embolism or other clinical sequelae;
• Epidural abscess;
• Rupture with fragmentation of the inflatable portion of the IBT resulting in
• Sepsis;
retention of a fragment within the vertebral body;
• Osteomyelitis;
• Rupture of the IBT causing contrast medium exposure, possibility resulting
in an allergic reaction or anaphylaxis; • Active infection;
• For a transpedicular approach, if the pedicle is not large enough or stable • Discitis;
enough to withstand the procedure, pedicle fracture may occur;
• Uncorrectable coagulopathy;
• Complications that may occur during a parapedicular approach include
pneumothorax and bleeding; • Symptomatic cord compression at the level of fracture;

• Avoid contact between the balloon and the bone cement; • Severe cardiopulmonary disease; and

• The balloon component of the Inflatable Bone Tamp may fail due to bone • Pregnancy
splinters and/or surgical tool contact; The bone tamp should not be used if the vertebral body, hand, tibia, radius
• Do not inflate the balloon until it has been fully deployed in the vertebral or calcaneus dimensions or fracture pattern do not allow safe placement and
body, hand, tibia, radius, or calcaneus. Inflating the balloon prior to full inflation of balloon.
deployment may result in balloon failure due to contact between the balloon CONTACT INFORMATION
and the access cannula; Globus Medical may be contacted at 1-855-639-6612. A surgical technique
• Do not use this product after the expiration date printed on the package. The manual may be obtained by contacting Globus Medical.
device may not be safe or effective beyond its expiration date; DIRECTIONS FOR USE – INFLATABLE BONE TAMP
• Deep or superficial wound infection; 1. Use the existing access channel through cancellous bone for cavity
creation.
• Retropathy, paresis or paralysis; and
2. Select the appropriate Inflatable Bone Tamp. Fill the Inflation Device with
• Bleeding or hematoma 60% contrast medium according to manufacturer’s instructions.
Certain degenerative diseases or underlying physiological conditions such 3. Turn the cap of the Stylet to tighten the Stylet into the Inflatable Bone Tamp.
as diabetes or rheumatoid arthritis may alter the healing process, thereby
increasing the risk of spinal fracture. 4. Attach the VacLok® Syringe from the Inflation Device Pack to the inflation
port of the Inflatable Bone Tamp.
Inflating the AFFIRM® Inflatable Bone Tamp balloon beyond the maximum
inflation volume may cause the balloon to rupture before reaching the 5. Pull the plunger of the VacLok® Syringe back and rotate to lock the plunger
maximum inflation pressure. in the position of the last slot to remove any air from the Inflatable Bone
Tamp prior to use.
Inflating the AFFIRM® Inflatable Bone Tamp balloon beyond the maximum
inflation pressure may cause the balloon to rupture before reaching the 6. Detach the VacLok® Syringe from the Inflatable Bone Tamp. Attach the
maximum volume. connection port of the Inflation Device to the inflation port of the Inflatable
Bone Tamp according to the Inflation Device manufacturer’s instructions.
PRECAUTIONS
Use of the AFFIRM® VCF System should be performed only by experienced 7. Place the Inflatable Bone Tamp through the access cannula into the
surgeons with specific training in the use of this system due to a risk of serious vertebra and advance to the intended location under fluoroscopic
injury to the patient. Preoperative planning and patient anatomy should be guidance.
considered prior to performing kyphoplasty. 8. When using the Curved Bone Tamp, retract the blue sleeve prior to balloon
Adequately instruct the patient. Mental or physical impairment which inflation.
compromises or prevents a patient’s ability to comply with necessary 9. Use AP and lateral fluoroscopy to ensure desired placement of the Inflatable
limitations or precautions may place that patient at a particular risk during Bone Tamp. Check the radiopaque band at the distal tip of the Inflatable
postoperative rehabilitation. Bone Tamp on fluoroscopy to verify location.
• Never use any gaseous medium to inflate the Inflatable Bone Tamp when it 10. Inflate the Inflatable Bone Tamp to 45psi to secure its position.
is inside the patient.
11. Inflate the Inflatable Bone Tamp under continuous fluoroscopy until
• Follow manufacturer’s instructions for contrast medium indications and the vertebral body wall or the endplate is touched, or the maximum
usage. Unintended contrast medium exposure to the patient may occur in pressure or maximum volume is achieved, according to the inflation
the use of the Inflatable Bone Tamp. chart parameters listed below. No cortical bone should be perforated.
• The Inflatable Bone Tamp should only be used when an inflation syringe is When using the Curved Bone Tamp, move the blue sleeve forward again,
attached. covering the balloon, before removing from the cannula.

• Inflatable Bone Tamps are intended for single use only. Do not re-sterilize 12. Once inflation is completed, deflate and remove the Inflatable Bone Tamp
and/or reuse it. under fluoroscopy.

34 | AFFIRM® Vertebral Compression Fracture System

 IMPORTANT INFORMATION ON AFFIRM® VCF SYSTEM – INFLATABLE BONE TAMP
13. Proceed to cement delivery. STORAGE
The AFFIRM® Inflatable Bone Tamp should be stored in its original shipping
materials. Proper care should be taken to ensure that the Inflatable Bone
Tamp will be not damaged. Store the Inflatable Bone Tamp in a cool, dry
place; 10°C - 40°C (50°F - 104°F).
Bone Tamp (1)
CAUTION: Federal (USA) Law Restricts this Device to Sale by or on the order
of a Physician.

INFLATION CHARTS SYMBOL TRANSLATION

AFFIRM® Premier (10P, 15P, 20P) for ø4.2mm working channel
CATALOGUE NUMBER STERILIZED BY IRRADIATION
Description Inflatable Inflatable Inflatable
Bone Tamp Bone Tamp Bone Tamp AUTHORISED
10P 15P 20P LOT NUMBER REPRESENTATIVE IN THE
EUROPEAN COMMUNITY
Max. Inflation 4cc ±0.4 4cc ±0.4 6cc ±0.4
Volume
CAUTION MANUFACTURER
Max. Inflation 400psi 400psi 400psi
Pressure (27ATM) (27ATM) (27ATM)
Nominal 17mm 16mm 17mm SINGLE USE ONLY Use by (YYYY-MM-DD)
Inflated
Diameter
Nominal 20mm 22mm 30mm QUANTITY
Inflated
Length
DI149A REV D
AFFIRM® Ultra (10U, 15U, 20U) for ø3.4mm working channel

Description Inflatable Bone Inflatable Bone Inflatable Bone

Tamp 10U Tamp 15U Tamp 20U
Max. Inflation 4cc ±0.4 5cc ±0.4 6cc ±0.4
Volume
Max. Inflation 400psi 400psi 400psi
Pressure (27ATM) (27ATM) (27ATM)
Nominal 16mm 16mm 17mm
Inflated
Diameter
Nominal 20mm 28mm 30mm
Inflated
Length

AFFIRM® Curved (10, 15, 20) for ø4.2mm working channel

Description Inflatable Inflatable Inflatable

Bone Tamp 10 Bone Tamp 15 Bone Tamp 20
Max. Inflation 4cc ±0.4 5cc ±0.4 6cc ±0.4
Volume
Max. Inflation 400psi 400psi 400psi
Pressure (27ATM) (27ATM) (27ATM)
Nominal 16mm 16mm 17mm
Inflated
Diameter
Nominal 20mm 28mm 30mm
Inflated
Length

UNCONSTRAINED INFLATION CHART

Ultra 10U (worst case unconstrained test condition)

Description Inflatable
Bone Tamp
10U
Inflation 7cc ±0.7
Volume
Inflation 118psi (8ATM)
Pressure

STERILIZATION
The AFFIRM® Inflatable Bone Tamp and Sleeve components are sterilized
by gamma radiation to ensure a Sterility Assurance Level (SAL) of 10-6. The
expiration date is provided on the package label. Do not use if expired. These
components are considered sterile unless the packaging has been opened or
damaged.

LIFE MOVES US | 35
 IMPORTANT INFORMATION ON FORTRESS® RADIOPAQUE BONE CEMENT
DESCRIPTION The liquid component is a powerful lipid solvent. It is recommended
FORTRESS™ Radiopaque Bone Cements (FORTRESS™ and FORTRESS- that all operating room staff who comes in contact with the material
Plus™) are radiopaque, self-curing, PMMA bone cements used to perform double glove to lessen the risk of contact dermatitis which may occur in
percutaneous vertebral augmentation procedures such as vertebroplasty susceptible individuals after long term exposure to the monomer. Wearing
or kyphoplasty. FORTRESS™ is packaged in two sterile components. One double gloves and adherence to the mixing instructions may diminish the
component is a vial containing 16.4g (full dose) or 8.2g (half dose) of possibility of hypersensitivity reactions. The mixed bone cement should
monomer. The monomer is a colorless, flammable liquid material with a not make contact with the gloved hand until the cement has acquired the
very distinctive odor of the following composition: consistency of dough. The liquid component should not be allowed to
come in contact with rubber or latex gloves.
Methyl Methacrylate 99.0% w/w
N:N Dimethyl-p-toluidine 1.0% w/w Avoid over pressurization of the bone cement because this may lead to
Hydroquinone 60 ppm extrusion of the bone cement beyond the site of its intended application
and damage to the surrounding tissues.
Hydroquinone is added to prevent premature polymerization. N:N
Dimethyl-p-toluidine is added to initiate polymerization at operating room Monomer can cause hypersensitivity in susceptible persons which may
temperatures. The liquid component is sterilized by filtration methods. produce an anaphylactic response.
The other component is a bottle containing 40.0g (full dose) or 20.0g (half Use in Pregnancy: Although the results of animal studies with similar
dose) of powder polymer with the following composition: materials have been negative, the safety of PMMA materials in pregnancy,
children, or by women of childbearing potential has not been established
Polymethyl Methacrylate / and requires that the potential benefits must be weighed against the
Methyl Methacrylate-styrene copolymer 72.0% w/w possible hazards to the mother, child, or fetus.
Benzoyl peroxide 0.7% w/w
Barium sulfate 28.0% w/w Adverse reactions in patients due to bone cements have affected the
cardiovascular system and in some cases hypotensive reactions have
Barium sulfate is added to make the material radiopaque. The powder resulted in cardiac arrest. Patients should be monitored for any change in
component is sterilized by gamma irradiation. blood pressure and pulse rate during and immediately following treatment
All components are single use and not re-sterilizable. Do not use if with bone cement.
packaging is opened or damaged. Precautions should be taken to detect and rectify the transitory fall in blood
INDICATIONS pressure that may occur when bone cement is introduced into a patient.
FORTRESS™ Radiopaque Bone Cement is indicated for the fixation of Clinical data indicates the need for good surgical principles and techniques
pathological fractures of the vertebral body using vertebroplasty or in delivery of bone cement. Postoperative infection is a serious condition
kyphoplasty procedures. Painful vertebral compression fractures may result and may require removal of the implanted bone cement. Postoperative
from osteoporosis, benign lesions (hemangioma), and malignant lesions infection may occur immediately or not manifest for several years.
(metastatic cancers, myeloma).
Use high quality motorized C-arm fluoroscopy, high quality biplanar
When used in conjunction with the REVLOK® or CREO® Fenestrated Screw fluoroscopy or real-time CT to guide needle insertion. Place the needle tip
System for posterior fixation, FORTRESS™ Radiopaque Bone Cements in the anterior third of the vertebral body.
are intended to restore the integrity of the spinal column even in the
absence of fusion for a limited time period in patients with advanced stage Polymerization of bone cement is an exothermic reaction, which occurs
tumors involving the thoracic and lumbar spine in whom life expectancy while it is hardening in situ. The released heat may damage bone or other
is of insufficient duration to permit achievement of fusion. FORTRESS™ surrounding tissues. The long term effect to surrounding tissues exposed
Radiopaque Bone Cements are limited to use at spinal levels where the to the exothermic temperatures produced by the polymerization process is
structural integrity of the spine is not severely compromised. not known.

WARNINGS Patient positioning should be maintained until the completion of the

polymerization process of the bone cement to achieve proper fixation. The
Read and understand these instructions. Familiarization with the bone
polymerization process may vary due to room temperature and delivery
cement prior to use is important.
system.
Cement leakage may cause tissue damage, nerve or circulatory problems,
Be aware that treating multiple levels may increase the risk of sudden drop
and other serious adverse events.
in blood pressure, particularly if more than three vertebral levels are treated
FORTESS™ Radiopaque Bone Cement is intended for single patient use. in a single operation.
DO NOT re-use or re-sterilize. Sterility is assured only if the package is
Delivery of excessive bone cement may lead to extrusion of the bone
unopened and undamaged.
cement beyond the intended application area and cause damage to
For safe and effective use of FORTRESS™ Radiopaque Bone Cement, surrounding tissues and the circulatory system.
the surgeon should be familiar with the material properties, handling
DO NOT deliver bone cement into a vertebral body without appropriate
characteristics and the application of the material and devices used for
imaging techniques such as high quality lateral fluoroscopic guidance.
mixing and dispensing the material. FORTRESS™ Radiopaque Bone Cement
should only be used by physicians familiar with percutaneous cement Long-term effects of bone cement in pathological fractures of the vertebral
delivery, vertebroplasty and kyphoplasty. body have not been established.
FORTRESS™ Radiopaque Bone Cement is not recommended for patients Leaks can also occur when injecting if the needle is in a vein or if unseen
that do not exhibit a pathologic condition, such as osteoporosis or a tumor microfractures are prevalent.
that would impair the ability of the patient to heal using conservative
treatment methods. Give proper consideration to other conventional If bone cement is seen outside of the vertebral body or in the circulatory
therapies prior to performing percutaneous vertebroplasty or kyphoplasty. system during percutaneous vertebroplasty or kyphoplasty, immediately
It is the responsibility of the physician to determine the appropriate stop the injection.
procedure, technique and device for each individual patient. Consider carefully the risk/benefit analysis for patients with malignant
Inadequate fixation or unanticipated postoperative events may affect the conditions who also have epidural extension or malignant collapse, in view
cement-bone interface and lead to micromotion of cement against bone of risk of precipitating cord compression. Ensure that immediate surgical
surface. Loosening of the bone cement may occur due to the development support is available.
of fibrous tissue between the bone cement and the bone. Long-term follow- Consider carefully the risk/benefit analysis for patients with traumatic burst
up is advised for all patients on a regularly scheduled basis. fractures with disruption of the posterior vertebral body..
Monomer is highly flammable. The operating room should be provided Adverse reactions affecting the cardiovascular system have been
with adequate ventilation to eliminate concentrated monomer vapor. attributed to leakage of unpolymerized monomer into the circulatory
Ignition of monomer fumes caused by use of electrocautery devices in system. Data indicates that the monomer undergoes rapid hydrolysis
surgical sites near freshly implanted bone cements has been reported. to methacrylic acid, and that a significant fraction of the circulating
Caution should be exercised during the mixing of the two components to methacrylate is in the form of free acid rather than the methyl ester.
prevent excessive exposure to the vapors which may produce respiratory Correlation between changes in circulating concentrations of methyl
irritation, irritation to the eyes and possibly the liver. Personnel wearing methacrylate/methacrylic acid and changes in blood pressure has not
contact lenses should NOT be near or involved in mixing this material. been established. Use proper technique to avoid laminations in the
material as well as entrapping air.

36 | AFFIRM® Vertebral Compression Fracture System

 IMPORTANT INFORMATION ON FORTRESS® RADIOPAQUE BONE CEMENT
Hypotensive reactions were reported to occur after introduction of bone DIRECTIONS FOR USE
cement between 10 to 165 seconds with duration of 30 seconds to 5-6 A dose is prepared by adding the entire contents of the liquid monomer to the
minutes. The patient should be monitored during and after the introduction entire contents of the powder. Do not add the powder to the liquid monomer.
of bone cement for any change in blood pressure, especially if the patient is
prone to high blood pressure and/or cardiovascular abnormalities.. 1. Using sterile technique and under sterile conditions, empty the entire
contents of the powder component into a sterile, inert mixing device.
PRECAUTIONS
This product should not be used after the expiration date printed on the 2. Add the entire contents of the liquid monomer to the powder. Mix the
package label. This device may not be safe or effective beyond its expiration material by following the device manufacturer’s instructions or until the
date. powder is completely saturated with the liquid monomer and the material
reaches the desired consistency. The handling characteristics and setting
Follow the handling and mixing instructions to avoid contact dermatitis. time of the material may vary with temperature, mixing technique and
Strict adherence to the instructions for mixing the powder and liquid humidity. Refer to the graphs and table below for additional information.
components may reduce the incidence of this complication.
3. Determine the preferred method or procedure for bone cement delivery
Adequately ventilate. into the patient and, if applicable, follow the device manufacturer’s
instructions.
Do not introduce other substances or foreign materials into this product.
Doughing and Hardening Times
Do not modify the mixing ratios in any form. Modification of the composition
can cause unpredictable handling characteristics, increased exposure
to the monomer component, increased risk of venous embolization and FORTRESS™ Plus Radiopaque Bone Cement
unpredictable final performance properties.
ADVERSE EVENTS
Serious adverse events, some with fatal outcome, associated with the use of
similar acrylic bone cements for vertebroplasty or kyphoplasty include:
• Myocardial infarction
• Cardiac arrest
• Cerebrovascular accident
• Cardiac embolism
• Pulmonary embolism
• Hypertension
• Hypotension
• Anaphylaxis
• Nerve entrapment

The most frequent adverse events reported are:

• Transitory fall in blood pressure
• Thrombophlebitis
• Trochanteric bursitis
• Trochanteric separation FORTRESS™ Radiopaque Bone Cement
• Hemorrhage and hematoma
• Surgical wound infection
• Superficial or deep wound infection
• Heterotopic bone formation
• Short-term cardiac conduction irregularities
Other adverse events reported are:
• Pyrexia due to an allergy to the bone cement
• Hematuria
• Dysuria
• Bladder fistula
• Delayed sciatic nerve entrapment due to extrusion of the bone cement
beyond the region of its intended application
• Adhesions and stricture of the ileum due to the heat released during
polymerization
Other reported adverse events for acrylic bone cements intended for
vertebroplasty or kyphoplasty include leakage of the bone cement beyond Handling Characteristics of FORTRESS™ Radiopaque Bone Cements at 23°C
the site of its intended application with introduction into the vascular system
Approximate Elapsed Time from Initiation of Mixing
resulting in embolism of the lung and /or heart or other clinical sequelae.
Time Point Activity
FORTRESS-Plus™ FORTRESS™
Although the majority of these adverse events present early within the post-
operative period, there have been some reports of diagnoses beyond a year or Mixing Period
Period to mix liquid and
0 – 40 seconds 0 – 60 seconds
powder components
more after the procedure.
Period during which
The physician must be aware of these possible reactions and be prepared to cement can be
Transfer Period 40 seconds – 3 minutes 1 – 10 minutes
treat them if they are encountered. transferred to delivery
system

CONTRAINDICATIONS
Time point at which
The use of FORTRESS™ Radiopaque Bone Cement is contraindicated in Doughing Time cement separates cleanly 3 minutes 10 minutes
from latex gloved finger
patients with:
• The presence of active or incompletely treated infection at the site where the Period during which
Working Period cement may be safely 3 – 15 minutes 10 – 23 minutes
bone cement is applied injected into bone void
• Allergies or sensitivity to methyl methacrylate or any of the chemical
compositions of the product Time point at which
cement is too hard to
Hardening Time 15 minutes 23 minutes
• Traumatic fractures of the vertebra that are nonpathological in nature effectively inject with
delivery device
• Cardiopulmonary disease
• Coagulation disorders
• Severe vertebral body collapse (vertebra plana) Hardening time may vary; the user should be aware of the behavior of the
• Prophylaxis with no evidence of acute fracture material and the operating room conditions.
• Clinically effective medical therapy HOW SUPPLIED
Individual Unit
Full Dose: One sterile package containing one bottle with 40.0g of powder
polymer and one vial with 16.4g of liquid monomer.

LIFE MOVES US | 37
 IMPORTANT INFORMATION ON FORTRESS® RADIOPAQUE BONE CEMENT
Half Dose: One sterile package containing one bottle with 20.0g of powder
polymer and one vial with 8.2g of liquid monomer.
SAFE DISPOSAL
The polymer component may be disposed in an authorized waste facility. The
liquid component can be evaporated under a vented hood or absorbed by an
inert material for disposal.
STORAGE
Warning: Flammable
Store below 25°C (77°F) and protect from light.
Device meets pyrogen limit specifications.
CONTACT INFORMATION
Globus Medical may be contacted at 1-866-GLOBUS1 (456-2871).
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of
a physician.

SYMBOL TRANSLATION

REFERENCE NUMBER USE BY (YYYY-MM-DD)

DO NOT USE A DAMAGED

LOT NUMBER
PRODUCT

QUANTITY PROTECT FROM LIGHT

STERILIZED BY GAMMA IRRADIATION ATTENTION, SEE

(Powder Component) INSTRUCTIONS FOR USE

UPPER TEMPERATURE LIMIT

STERILIZED BY FILTRATION
25° C
(Liquid Component)
77° F

STERILIZED BY ETHYLENE OXIDE

FLAMMABLE
(Contents of Blister Pack)

SINGLE USE ONLY MANUFACTURER

DI175A REV H

38 | AFFIRM® Vertebral Compression Fracture System

NOTES

LIFE MOVES US | 39
 Globus Medical
Valley Forge Business Center
2560 General Armistead Avenue Customer Service:
Audubon, PA 19403 Phone 1-866-GLOBUS1 (or 1-866-456-2871)
www.globusmedical.com Fax 1-866-GLOBUS3 (or 1-866-456-2873)

© 2022 Globus Medical. All rights reserved. Patent www.globusmedical.com/patents.

Life moves us is a registered trademark of Globus Medical. Please refer to package insert for ATTGD01
description, indications, contraindications, warnings, precautions and other important information. 09.22 Rev E