Zimmer Biomet The AperFix User manual

The AperFix®System
The Anatomic Implant
PCL Surgical Technique

Table of Contents
Posterior Cruciate Ligament Review ........................................................................ 2
Graft Preparation and Tunnel Placement................................................................. 2
Femoral Fixation and Graft Passage ........................................................................ 5
Tibial Fixation............................................................................................................ 7
Ordering Information ............................................................................................. 10
Indications .............................................................................................................. 11

2 | AperFix System PCL Surgical Technique
Step 2
Whip stitch approximately 20 mm of the graft ends
with a sturdy suture (#2 non-absorbable) in the
standard fashion.
• It is recommended to use two dierent colored
sutures to distinguish between the graft bundles.
Step 3
Double the graft over at its mid length, then pull
the graft bundles through the Graft Sizing Block to
determine the diameter of the implant to be used.
Select a diameter which the graft bundle passes tightly
through. Please refer to the sizing table above.
Step 4
Pass the prepared soft tissue grafts through the
eyelets of the AperFix Femoral Implant (AperFix 29
mm shown) (Figure 1).
Note: Taper graft ends for easier graft loading
through the implant.
Posterior Cruciate Ligament Review
Primary restraint to posterior tibial translation:
• Larger anterolateral (AL) bundle tight in 90° flexion
• Posteromedial (PM) bundle tight in extension
Origin:
• Femur: 8-10 mm posterior to the anterior articular
surface of the medial femoral condyle
• Tibia: 15 mm distal to the posterior tibial plateau
Graft Preparation
and Tunnel Placement
Step 1
The recommended graft choice is an anterior or
posterior allograft tendon at least 240 mm in length
(when doubled over, graft should ideally fit an 11 mm
implant to maximally fill the PCL footprint). Split the
graft longitudinally to half of its length (pant leg).
Note: Autograft hamstring tendon may also be
used.
Figure 1

3 | AperFix System PCL Surgical Technique
Figure 3Figure 2
Step 7
Anterolateral scope portal should be made 10-12 mm
from the patellar tendon to facilitate femoral drilling.
Graft Preparation
and Tunnel Placement (cont.)
Step 5
Wrap the sutures of the prepared tendons around the
suture cleats of the Femoral Inserter Handle to pre-
tension the graft (Figure 2).
Note: To achieve optimal anatomic placement of
the bundles, it is recommended to wrap the AL
graft bundles on one suture cleat and PM graft
bundles on the opposite suture cleat.
Step 6
Make a horizontal mark on the top of the tendon
bundles at the inferior edge of the implant to serve as
the aperture depth indicator (Figure 3).
Note: It is recommended to make a second mark on
the grafts that will represent the AL bundle, at both
the implant end and sutured end to help orient the
bundles in the joint space.

4 | AperFix System PCL Surgical Technique
Note: A posteromedial portal is recommended
to fully debride the posterior tibia for tunnel
positioning, suture management, and graft
passage.
Step 10
Use a curette posteriorly to protect the neurovascular
structures and place the PCL guide parallel to the tibial
plateau. Pass the drill tipped guide wire through the
PCL guide to the posterior tibial cortex (Figure 5).
Note: Use fluoroscopic imaging to confirm proper
pin placement.
Step 11
Using the appropriate size tibial drill, carefully ream
the tibial tunnel.
Note: Fluoroscopic and direct visualization should
be used as guidance.
Graft Preparation
and Tunnel Placement (cont.)
Step 8
Drill the femoral tunnel first to avoid fluid outflow
through the tibial tunnel.
• With the knee flexed between 90° and 120° (Figure
4), insert a guide wire through the lateral portal to
the center of the PCL footprint (approximately 6-8
mm posterior to the articular surface of the medial
femoral condyle). Create the femoral socket using
the sizing table below:
Femoral Implant Femoral Socket Length
AperFix AM 24 mm 25 mm minimum
AperFix 29 mm 30 mm minimum
Step 9
Flex the knee to 45° and place a transtibial PCL guide
through the medial portal to the PCL insertion location
(approximately 1.5 cm distal to the tibial articular
surface and slightly lateral to midline).
Figure 5Figure 4

5 | AperFix System PCL Surgical Technique
Step 3
To optimize anatomic femoral placement of the graft
bundles, rotate the AperFix inserter until the AL
bundle is positioned anterior and the PM bundle is
positioned posterior in the femur (Figure 8).
Step 4
Ensure the implant is in proper position, then pull the
safety pin out of the Inserter Handle (Figure 9).
Femoral Fixation and Graft Passage
Step 1
Load a looped, high tensile strength suture through
the tibial tunnel; retrieve through the intercondylar
notch and out of the anterolateral portal. Suture loop
will be used to shuttle the graft bundles independently
through the “killer turn” (Figure 6).
Note: Place hemostats on the ends of the retrieval
suture loops to keep the sutures in position while
inserting the AperFix femoral implant.
Step 2
Insert the prepared AperFix device through the lateral
portal and into the femoral socket to the marked depth
location. Confirm the implant is fully seated into the
socket (Figure 7).
• Maintain the same knee flexion angle that was
positioned during femoral socket drilling.
Figure 6
Figure 7
Figure 8
Figure 9

6 | AperFix System PCL Surgical Technique
Step 8
Feed the sutures of the tendon bundles through the
retrieval suture loop. Shuttle the tails of the AL and
PM bundles through the tibial tunnel by pulling gently
on the suture loop from the tibial tunnel end.
Note: Care should be taken to allow the sutures to
pass through the AL portal first and exit the tibial
tunnel prior to allowing the grafts to pass into the
knee.
Step 9
Place a probe or hemostats between the tendons and
the knee to maintain tension on the grafts as they
begin to enter the lateral portal. Once the graft ends
have been pulled in, release tension and allow the
AL and PL bundles to pass through the tibial tunnel
independently (Figure 12).
Femoral Fixation and Graft Passage
(cont.)
Step 5
With the Inserter Handle held firmly in place, rotate
the white implant deployment knob clockwise until
the deployment knob can no longer be turned and
comes into contact with the purple handle (Figure 10).
Step 6
Disengage the tendon sutures from the suture cleats.
Step 7
Release the Inserter Handle from the implant by
pulling back on the Implant Release Knob. Remove the
Inserter Handle from the operating site and discard
(Figure 11).
Figure 11
Figure 10
Figure 12

7 | AperFix System PCL Surgical Technique
Step 3
Insert the Guide Wire through the Tendon Expander,
into the tibial tunnel (between the tendons), and into
the joint space (Figure 15).
• Confirm the Guide Wire is in the joint space.
Tibial Fixation
Step 1
With the AL and PM bundles anatomically separated,
select the Tibial Implant size to match the drilled
tunnel diameter (Figure 13).
Note: The Tibial Implant will come with a Tendon
Expander, Guide Wire, Cannulated Screw, and
a Driver pre-loaded with the Tibial Sheaths and
Sheath Holder.
Step 2
Hold the Tendon Expander arms perpendicular to the
tibial tunnel and wrap the sutures from the tendon
bundles around the suture cleats, such that the sutures
are first inserted in the lateral slits and then wrapped
around the vertical cleats (Figure 14).
Figure 13 Figure 15
Figure 14

8 | AperFix System PCL Surgical Technique
Step 5
Pull the Driver back along the Guide Wire to disengage
from the Tibial Sheaths (Figure 17).
• Verify the tabs are fully seated against the cortex.
Step 6
Remove the Sheath Holder from the Driver and
securely place the Tibial Screw on the end (Figure 18).
Tibial Fixation (cont.)
Step 4
With the knee held at 90° and under an anterior tibial
force, and with the graft under tension (to simulate
the larger AL bundle), insert the Tibial Sheaths over
the Guide Wire and into the tibial tunnel such that the
cortical engagement tabs are in the 12 o’clock position
(Figure 16).
• The Tibial Sheaths should be positioned with the
tabs fully seated against the tibia.
Figure 16
Figure 17 Figure 18

9 | AperFix System PCL Surgical Technique
Tibial Fixation (cont.)
Step 7
Keep the knee in 90° of flexion and insert the Tibial
Screw over the Guide Wire until the tip of the Screw
engages the Sheaths (Figure 19).
• Use the “Easy Start” feature of the Tibial Screw by
aligning the flat tip parallel with the Sheaths prior
to deployment.
Step 8
With forward pressure, turn the Driver clockwise until
the screw head is flush with the superior rim of the
cortical wall. Maintain tension on the graft to prevent
loss of graft stiness.
• The Tibial Screw threads match that of the Sheath,
therefore excessive torque is not needed to engage
and insert the Screw.
Step 9
Once the Tibial Screw is completely seated between
the Sheaths, remove the Driver by pulling the handle
straight back. Remove the Guide Wire (Figure 20).
• Confirm the integrity of the repair.
• Trim the excess suture and tendon flush with the
tibial surface.
*Refer to the product Instructions For Use (IFU) insert for a list of contraindications, warnings, and precautions.
Figure 19 Figure 20

10 | AperFix System PCL Surgical Technique
Ordering Information
AperFix Femoral Implant with Inserter
Description Size Part Number
AperFix AM Femoral Implant with Inserter 9 mm x 24 mm
10 mm x 24 mm
CM-2409
CM-2410
AperFix Femoral Implant with Inserter 9 mm x 29 mm
10 mm x 29 mm
11 mm x 29 mm
CM-2909
CM-2910
C M - 2 911
AperFix Disposable Instruments
Description Size Part Number
Calibrated Drill Tipped Guide Wire 2.4 mm x 14” CM-7014
ACL Disposable Procedure Kit CM-1501
Accessory Portal Kit with Low Profile Drill
and EZ Shuttle®Suture Loop
9 mm
10 mm
11 m m
CM-7609
CM-7610
C M -7611
Aperfix II Tibial Implant with Driver
Description Size Part Number
Tibial Implant with Driver 8 mm x 30 mm CM-3008
Cannulated Tibial Implant with Driver 9 mm x 30 mm
10 mm x 30 mm
11 mm x 30 mm
CM-3009C
CM-3010C
CM-3011C

11 | AperFix System PCL Surgical Technique
APERFIX / APERFIX AM FEMORAL IMPLANT
INDICATIONS FOR USE
The AperFix Femoral Implant is intended for use
in tenodesis procedures with soft tissue grafts,
utilizing either arthroscopic or open techniques
during Anterior Cruciate Ligament (ACL), Posterior
Cruciate Ligament (PCL), Medial Collateral Ligament
(MCL), Lateral Collateral Ligament (LCL), and Medial
Patellofemoral Ligament (MPFL) reconstruction.
CONTRAINDICATIONS
1) Fixation using Bone-Patella Tendon-Bone or
Quads Tendon grafts.
2) Surgical procedures other than those listed
in the INDICATIONS section.
3) Presence of infection.
4) Patient conditions including insucient quantity
or quality of bone or soft tissue.
5) Insucient blood supply or previous infections
which may hinder the healing process.
6) Foreign body sensitivity. If material sensitivity
is suspected, testing should be completed prior
to device implantation.
7) The use of this device may not be suitable for
patients with immature bone. The physician
should carefully assess the status of the physes
of the distal femur and proximal tibia before
performing ACL reconstruction surgery on
patients who are skeletally immature.
8) Conditions which may limit the patient’s ability
or willingness to follow postoperative care
instructions.
APERFIX TIBIAL IMPLANT
INDICATIONS FOR USE
The Cayenne Medical AperFix Tibial Implant with
Inserter is intended for use in tenodesis procedures
with soft tissue grafts, utilizing either arthroscopic
or open techniques during Anterior Cruciate
Ligament (ACL), Posterior Cruciate Ligament (PCL),
Medial Collateral Ligament (MCL), Lateral Collateral
Ligament (LCL), and Medial Patellofemoral Ligament
(MPFL) reconstruction.
CONTRAINDICATIONS
1) Fixation using Bone-Patella Tendon-Bone grafts.
2) Surgical procedures other than those listed
in the INDICATIONS section.
3) Presence of infection.
4) Patient conditions including insucient quantity
or quality of bone or soft tissue.
5) Insucient blood supply or previous infections
which may hinder the healing process.
6) Foreign body sensitivity. If material sensitivity
is suspected, testing should be completed prior
to device implantation.
7) The use of this device may not be suitable for
patients with immature bone. The physician
should carefully assess the status of the physes
of the distal femur and proximal tibia before
performing ACL reconstruction surgery on
patients who are skeletally immature.
8) Conditions which may limit the patient’s ability
or willingness to follow postoperative care
instructions.

12 | AperFix System PCL Surgical Technique
Notes

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warnings, precautions, potential adverse eects and patient counselling
information, see the package insert and www.zimmerbiomet.com.
Check for country product clearances and reference product specific
instructions for use.
Zimmer Biomet does not practice medicine. 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. Caution:
Federal (USA) law restricts this device to sale by or on the order of a
surgeon. Rx only.
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