Zimmer Biomet Avenue T User manual

Avenue® T
TLIF Cage
Thoracolumbar Solutions
Surgical Technique Guide
erteBRIDGE®
PLATING TECHNOLOGY
with

2 Avenue®T TLIF Cage—Surgical Technique
2
VerteBRIDGE® Plating is the integrated fixation
designed specifically for the
Avenue T cage.

Avenue®T TLIF Cage—Surgical Technique Guide 3
Zimmer Biomet Spine does not practice
medicine. This technique was developed in
conjunction with health care professionals.
This document is intended for surgeons
and is not intended for laypersons. Each
surgeon should exercise his or her own
independent judgment in the diagnosis and
treatment of an individual patient, and this
information does not purport to replace
the comprehensive training surgeons have
received. As with all surgical procedures, the
technique used in each case will depend on
the surgeon’s medical judgment as the best
treatment for each patient. Results will vary
based on health, weight, activity and other
variables. Not all patients are candidates
for this product and/or procedure.
Patient Positioning 4
Facetectomy and Disc Space Preparation 5
Distraction 6
Discectomy and Endplate Preparation 7
Implant Size Selection 8
Cage Preparation 9
Implant to Cage Holder Assembly 10
Cage Insertion 12
Plate Insertion 13
Cage Holder Removal and Final Verification 15
Supplemental Fixation 16
Implant Removal for Revision 17
Implant Kit and Instrument Set 21
Device Description and Use Guidelines 22
TABLE OF CONTENTS

4 Avenue®T TLIF Cage—Surgical Technique Guide
STEP 1
Place the patient in the prone or knee-chest position on a
radiolucent operating table. Adjust the table (as needed)
so that the C-Arm provides true A/P images when at 90°
and true lateral images at 0°.
Figure 1
OR layout
PATIENT POSITIONING

Avenue®T TLIF Cage—Surgical Technique Guide 5
STEP 2
Depending on the pathology, it may be necessary to
partially or fully resect the facet joint and/or the lamina. A
facetectomy and/or laminotomy is performed using the
surgeon's preferred technique and instruments.
Nerve root retractors (6 and 10mm) may be used to
protect surrounding nerve structures.
Note: Facet resection is not mandatory, if the approach
allows sufficient access for the discectomy.
Identify the desired disc and start disc resection using
a scalpel. Perform the discectomy using the surgeon's
preferred technique and instruments (e.g. cobbs, pituitary
rongeurs, or curettes) (Figure 2 ).
FACETECTOMY AND DISC SPACE PREPARATION
Figure 2
Facet resection for a TLIF approach

6 Avenue®T TLIF Cage—Surgical Technique Guide
STEP 3
Gradually distract the disc space using the paddle
distractors, available in 1mm increments. The final disc
height achieved should be consistent with the disc
heights of the adjacent levels (Figure 3).
Note: Proper distraction is required to achieve and
maintain desired disc height. Complete a thorough
discectomy to ensure that the proper implant size is
chosen. 0° paddle distractors in 6 and 7mm heights do
not refer to an available cage size in the system and are
provided for initial distraction.
Figure 3
Distraction
DISTRACTION

Avenue®T TLIF Cage—Surgical Technique Guide 7
Figure 4a
Shaver
DISCECTOMY AND ENDPLATE PREPARATION
STEP 4
Use the shavers to continue the discectomy and prepare
the vertebral endplates (Figure 4a).
Complete the discectomy and prepare the grafting
surfaces with straight and/or angled right or left curettes
(Figures 4b/4c).
Note: Angled curettes can be used to complete the
resection in areas of reduced access or to clear an area for
additional bone graft insertion.
Caution: Do not use shavers for distraction of the
interbody space.
Caution: Endplate preparation should result in
vascularization between the endplate and bone graft
without weakening the cortical bone.
Figure 4c
Angled curette
Figure 4b
Straight curette

8 Avenue®T TLIF Cage—Surgical Technique Guide
IMPLANT SIZE SELECTION
STEP 5
Paddle distractors or trials are used to select implant
size (height, length, and lordosis) best suited to the
patient's anatomy. Paddle distractors and trials are
available for each implant height and lordosis (Figures
5a/5b). Markers present on the paddle distractors
and trials allow for the surgeon to determine the
appropriate implant length (30mm or 34mm), under
fluoroscopy (Figure 5c).
Position the paddle distractor or trial in the desired
position. The paddle distractor or trial should fit
securely within the disc space, but care should be taken
to avoid oversizing the implant.
Confirm the position of the paddle distractor or trial
using fluoroscopy.
• A/P View: Lateral coverage and rotational position
(the more visible the paddle hole, the more rotation
in the axial plane) (Figure 5d).
• Lateral View: Length, height, lordosis, and
anteroposterior positioning (the posterior edge of
the cage should end 2 to 5mm away from the
posterior vertebral walls).
Once the proper size is determined, remove the paddle
distractor or trial from the intervertebral space.
Example: The best cage length here is 34mm. Paddle
distractors and trials can also be used to determine the
appropriate lordosis and height (Figure 5e).
Figure 5a
5° H12mm paddle distractor
Figure 5b
5° trial
Figure 5c
Axial View
Figure 5d
A/P View
Figure 5e
Lateral View
30mm
34mm
This side points
to the left side
of collar
2 to 5mm
34
mm
30
mm

Avenue®T TLIF Cage—Surgical Technique Guide 9
CAGE PREPARATION
KNOB
STEP 6
The graft fusion chamber must be filled with allograft
or autograft.
Place the cage in the graft support and lock the cage
by turning the graft support knob.
Compact the draft in the bone graft chamber of the
cage using the graft compactor (Figure 6).
Figure 6
Graft fusion chamber

10 Avenue®T TLIF Cage—Surgical Technique Guide
CAGE HOLDER BODY
KNOB
GROOVE
RETAINING WING
THREADED ROD
STEP 7
Slide the inner threaded rod inside the cage
holder body.
Bring the cage close to the cage holder and position
the retaining wing of the cage holder on each side of
the cage. Align and insert the inner threaded rod into
the threaded hole on the cage.
Tighten the cage on the cage holder by turning the
cage holder knob (Figure 7).
Caution: The connection between the cage and the
cage holder is critical. Tighten until the connection is firm
but not excessive in order to avoid damaging the screw
thread.
Caution: Confirm the grooves in the knob align with the
grooves in the cage holder handle, so that the impactors
can be introduced.
IMPLANT TO CAGE HOLDER ASSEMBLY
Figure 7
Cage holder assembly

Avenue®T TLIF Cage—Surgical Technique Guide 11
STEP 8
Select the plate length (S or M) and insert the plate
holders on each side of the cage holder (Figure 8a).
Plates are pre-assembled in a single-use plate holder
made of PEEK CLASSIX™.
Markings on the plate holders should face the cage
holder and the peg must be locked into the slots on the
cage holder (Figure 8c).
Insert impactors on each side of the cage holder handle
and slide them until they are locked by the flexible
blades. The distal tips of the impactors must
be engaged inside the plate holders (Figure 8b).
Figure 8a
Cage holder assembly
Figure 8c
Plate holders length
PEG
MARKING
PLATE
HOLDER
SLOT
LOCKED HOLDERS
Figure 8
Toeing pad position
Figure 8b
Cage holder assembly
IMPACTOR
LOCKED
IMPACTORS
FLEXIBLE
BLADE
IMPACTOR

12 Avenue®T TLIF Cage—Surgical Technique Guide
Note: Anterior marker is 1mm from the anterior cage
border. Central markers are 1mm from the lateral cage
borders (Figure 9b).
CAGE INSERTION
Figure 9b
Markers
STEP 9
Prior to cage insertion, bone graft material may be
placed anteriorly or contralaterally.
Insert the cage into the interbody space with successive
impactions on the cage holder, parallel to the endplates.
A non-parallel insertion may weaken the end plates due
to conflict with the cage.
Take care to position the cage as close as possible to its
final position.
Confirm proper implant placement using fluoroscopy
(Figure 9):
A/P View: Lateral and rotational positioning
Lateral View: Anteroposterior and rotational
positioning
Figure 9
Proper implant placement
ANTERIOR
MARKER
LATERAL VIEW
A/P VIEW
ANTERIOR
MARKER
CENTRAL MARKERS
1mm
1mm
1mm
5mm
LOCKING
PINS

Avenue®T TLIF Cage—Surgical Technique Guide 13
STEP 10
Once the final cage position is achieved, the plates can
be inserted. The impaction of the plates is performed
simultaneously. If a pedicle screw system is already
inserted, plate insertion must be done with care to avoid
any interference between both constructs (Figure 10).
In normal bone structure, the insertion of the plates is
a simple step. Avoid applying excessive force to insert
plates.
Engage the double impactor on the proximal side of the
cage holder until it contacts the impactors.
PLATE INSERTION
Figure 10
Plate Insertion
DOUBLE
IMPACTOR CONTACT
LOCKED IMPACTORS UNLOCKED IMPACTORS
FLEXIBLE
BLADE

14 Avenue®T TLIF Cage—Surgical Technique Guide
PLATE INSERTION (continued)
Figu re 11a
Plate Insertion
Figu re 11b
Lateral View
STEP 11
Manually push the double impactor to advance the
impactors and bring the tips of the plates in contact with
the vertebral endplates.
Caution: Check the alignment of the cage holder with
the cage before starting impaction of the plates. If the
cage and the cage holder are misaligned, the plates won't
be able to follow their predefined trajectory, resulting in
contact with the cage.
Impact the double impactor with a mallet until the
mechanical stop is reached while holding the cage
holder handle firmly to prevent advancement of the
cage (Figure 11a).
Caution: Once the impactors have reached the
mechanical stop, impaction with the mallet must be
stopped. Plates are inserted and locked inside the cage.
Use fluoroscopy to check proper plate positioning
(Figure 11b).
MECHANICAL
STOP

Avenue®T TLIF Cage—Surgical Technique Guide 15
CAGE HOLDER REMOVAL AND FINAL VERIFICATION
STEP 12
Remove the double impactor.
Unscrew the knob to disengage the cage from the cage
holder (Figure 12a).
Remove the cage holder.
Use A/P and lateral fluoroscopy to confirm final implant
positioning (Figure 12b/12c).
Caution: Do not impact the plate and the cage once the
cage holder has been removed.
Discard the plate holders at the end of the procedure.
Figure 12a
Cage holder removal
Figure 12b
A/P View
Figure 12c
Lateral View

16 Avenue®T TLIF Cage—Surgical Technique Guide
The Avenue T TLIF Cage system is designed for use
with or without integrated fixation and must be used in
conjunction with supplemental fixation cleared by FDA
for use in the lumbar spine.
Implant the supplemental fixation according to the
recommended surgical technique for the specific
system used.
Caution: If using a pedicle screw system as supplemental
fixation, care should be taken to avoid interference
between the screws and VerteBRIDGE plates.
SUPPLEMENTAL FIXATION

SLOTTED MALLET
REMOVAL SCREWDRIVER
REMOVAL HANDLE
REMOVAL TUBE
REMOVAL HOOK
REMOVAL HOOK GUIDE
UNLOCKING
THREADED SHAFT
REVISION
THREADED SHAFT
Avenue®T TLIF Cage—Surgical Technique Guide 17
Figure 13
Implant removal tools
STEP 13
If needed, the unlocking threaded shaft facilitates
removal of the plates from the cage. If insertion of
the unlocking threaded shaft is too difficult, use the
revision threaded shaft and restart the removal steps
(Figure 13).
Important: Never reuse a cage or plates.
IMPLANT REMOVAL FOR REVISION

18 Avenue®T TLIF Cage—Surgical Technique Guide
IMPLANT REMOVAL FOR REVISION (continued)
STEP 14
Screw the removal tube onto the unlocking
threaded shaft (Figure 14a).
Insert the removal screwdriver inside the tube.
To unlock the plates, screw the removal assembly
into the threaded hole on the posterior side until
it stops turning (Figure 14b).
Caution: Make sure to protect the dura and
nerve roots during revision.
Figure 14a
Implant removal tube
Figure 14b
Implant plate removal

Avenue®T TLIF Cage—Surgical Technique Guide 19
REMOVAL
HOOK
STEP 15
Remove the removal screwdriver and leave the
threaded shaft and removal tube.
Insert the removal hook in the revision hole of the first
plate to remove (Figure 15a).
The removal hook must be parallel to the removal tube
(Figure 15b).
Figure 15b
Insert removal hook
Figure 15a
Find removal hole
REVISION
HOLE
STEP 16
Position the removal hook guide on the tube and
removal hook to ensure both are parallel and positioned
together. This facilitates removal of the first plate
(Figure 16a/16b).
Figure 16a
Guide approach
Figure 16b
Final position of the guide

20 Avenue®T TLIF Cage—Surgical Technique Guide
STEP 17
Place the slot of the slotted mallet across the removal
hook guide. Impact under the removal hook handle with
the slotted mallet to remove the plate. Keep the removal
hook's handle and the guide together to help guide
plate removal (Figure 17a).
Note: The guide can be removed and the removal hook
can be replaced with forceps to grab the plate partly
inserted in the bone to complete its removal.
When the first plate is removed, repeat the steps to
remove the second plate while making sure the guide is
positioned on the side of the hook.
Screw the removal handle on the removal tube
(Figure 17b).
Gradually remove the cage using the slotted mallet
(Figure 17c).
IMPLANT REMOVAL FOR REVISION (continued)
Figure 17a
Position slotted mallet for removal
REMOVAL HOOK
OR FORCEPS
PLATE PARTLY
INSERTED INTO
BONE
Figure 17c
Remove cage
Figure 17b
Scew removal handle