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SYNFIX® EVOLUTION SYSTEM
Implants and Instruments for Stand-alone Anterior Lumbar Interbody Fusion
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SUMMARY
• SYNFIX® Evolution Implants and Instruments: Overview of Features
• Design Rationale
– Biomechanical Stability
– Procedural Efficiencies
– Comprehensive Implant Portfolio
• Surgical Steps
• Triple Aim
• ALIF Evolution Family
• Tips and Tricks
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OVERVIEW of FEATURES
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SYNFIX EVOLUTION IMPLANTS
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SYNFIX EVOLUTION IMPLANTS
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SYNFIX EVOLUTION INSTRUMENTS
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SYNFIX EVOLUTION INSTRUMENTS Evolution SQUID™ Inserter/Distractor Option
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INDICATIONS
The SYNFIX Evolution Secured Spacer
System is a stand-alone anterior interbody
fusion device indicated for use in patients with
degenerative disc disease (DDD) at one or
two contiguous levels from L2 to S1. These
DDD patients may also have up to Grade I
spondylolisthesis at the involved level(s). The
interior of the spacer component of the
SYNFIX Evolution can be packed with
autograft.
DDD is defined as back pain of discogenic
origin with degeneration of the disc confirmed
by history and radiographic studies. These
patients should be skeletally mature and have
had six months of non-operative treatment.
INDICATIONS AND CONTRAINDICATIONS
CONTRAINDICATIONS
1. Use of the SYNFIX Evolution is contraindicated when there is 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 (PEEK OPTIMA LT-1, Tantalum, Titanium, Aluminum and/or niobium).
2. Severe osteoporosis may prevent adequate fixation and thus preclude the use of
this or any other orthopaedic implant.
3. Conditions that may place excessive stresses on bone and implants, such as
severe obesity or degenerative diseases, are relative contraindications. The
decision whether to use these devices in patients with such conditions must be
made by the physician taking into account the risks versus the benefits to the
patient.
4. Use of these implants is relatively contraindicated in patients whose activity,
mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle
may interfere with their ability to follow postoperative restrictions. These patients
may place undue stresses on the implant during bony healing and may be at a
higher risk of implant failure.
5. Use of the SYNFIX Evolution is contraindicated when patient anatomy or
pathology prevents insertion of all four locking screws.
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DESIGN RATIONALE
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Procedural Efficiencies
Comprehensive Implant Portfolio
DESIGN RATIONALE
Biomechanical Stability
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Procedural Efficiencies
Comprehensive Implant Portfolio
DESIGN RATIONALE
Biomechanical Stability
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BIOMECHANICAL STABILITY Key Features
PEEK ~ Cortical Bone
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BIOMECHANICAL STABILITY* Compared to 360°Fusion
0
1
2
3
4
5
6
7
8
9
Flexion*(6 Nm)
Extension*(6 Nm)
LateralBending*(6 Nm)
AxialRotation**
(6 Nm)
Ra
ng
e o
f M
otio
n (°)
Intact
SYNFIX® LR Implant
360°Fusion
1Cain et al (2005): A new stand-alone ALIF device: Biomechanical comparison with established fixation methods
*Biomechanical test results may not necessarily be indicative of clinical performance
The SYNFIX® LR Implant is equivalent to 360°fusion in flexion,
extenson and lateral bending; superior in axial rotation.1
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BIOMECHANICAL STABILITY* Compared to Competitive Products
3 Variable Angle Screws Medtronic
SOVEREIGN® Interbody Device
Blade Fixation LDR Spine
ROI-A® ALIF Cage
4 Variable Angle Screws Centinel Spine
STALIF TT® Cage
1Freeman et al (2016): Biomechanical comparison of stand-alone anterior lumbar interbody fusion devices
with secured fixation: Four-screw locking plate vs Three-screw variable angle vs. blade fixation 2Schleicher et al (2008) Biomechanical comparison of two different concepts for stand-alone anterior lumbar
interbody fusion
*Biomechanical test results may not necessarily be indicative of clinical performance
The SYNFIX LR Implant demonstrates superior biomechanical
stability compared to other stand-alone ALIF products 1,2
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AO principles Key criterion to promote
bone formation and solid fusion1
BIOMECHANICAL STABILITY Clinical Outcome
1Aebi et al (2007) AOSPINE Manual
2Ardern et al (2008) Clinical and radiological outcomes of stand-alone anterior lumbar interbody fusion used
to treat discogenic pain: Two year results of the SynFix-LR device. 3Siepe et al (2015) Anterior stand-alone fusion revisited: a prospective clinical X-ray and CT investigation
Clinical Experience SYNFIX LR Implant as effective as 360°
fusion in achieving fusion in the
management of discogenic back pain over
one and two levels.2,3
97.3% fusion rate reported with the
SYNFIX LR Implant 3
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Procedural Efficiencies
Comprehensive Implant Portfolio
DESIGN RATIONALE
Biomechanical Stability
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PROCEDURAL EFFICIENCIES Reduced Number of Instrument Passes
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PROCEDURAL EFFICIENCIES Rapid Screw Insertion & Enhanced Design for Surgeon Handling
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PROCEDURAL EFFICIENCIES Minimally Invasive Enabled Anterior Access
Potentially Leading to Reduced Hospital Stay, Blood Loss, Intraoperative Time 1
1Lammli et al (2014) Stand-alone Anterior Lumbar Interbody Fusion for Degenerative Disc Disease of the
Lumbar Spine
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Procedural Efficiencies
Comprehensive Implant Portfolio
DESIGN RATIONALE
Biomechanical Stability
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COMPREHENSIVE IMPLANT PORTFOLIO
6 Footprints
4 Angles 126 Implant Options
6 Heights
18° Medium
36mm x 28mm
10.5mm
12mm
13.5mm
15mm
17mm
19mm
10° 14° 6° Large
40mm x 31mm
Small
32mm x 25mm
Footprints Angles & Heights
Medium Deep
36mm x 31mm
Large Deep
40mm x 34mm
Small Deep
32mm x 28mm
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COMPREHENSIVE IMPLANT PORTFOLIO Support Sagittal Restoration & Maximized Graft Volume
Sagittal Restoration
is correlated with good
clinical outcome1
1Le Huec et al (2014) Evidence showing the relationship between sagittal balance and clinical outcome in
surgical treatment of degenerative spinal diseases: a literature review.
Graft retention ridge Central strut enhances graft fixation
Optimized lumen
design to maximize
graft/fusion volume
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COMPREHENSIVE IMPLANT PORTFOLIO Reduced Risk of Subsidence
R1
R2
R2 > R1
Appropriate choice of
cage footprint
potentially reduces
risk of subsidence 1
S
M
L
SD
MD
LD
1Michaela et al (2008) Footprint mismatch in lumbar total disc arthroplasty
Asymmetrical
anatomic convexity
to fit lumbar and
lumbosacral
endplates
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Fine tip
Dual lead
Cortical thread
Blunt tip
COMPREHENSIVE IMPLANT PORTFOLIO Screws
20 mm, 25 mm and 30 mm
lengths available
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SURGICAL STEPS
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SURGICAL STEPS
Access
Discectomy Trialing
Distraction
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Option B: Evolution
SQUID™ Inserter
SURGICAL STEPS
Implant Preparation
Option A:
Aiming Device
Cage Insertion
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Screw Preparation
SURGICAL STEPS
Pilot Hole Creation
Screw Insertion
Final Tightening
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SURGICAL STEPS
Screw Removal Cage Removal
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TRIPLE AIM
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TRIPLE AIM Strategic Fit of the SYNFIX Evolution System
Primary biomechanical
stability is a key AO
principle for succesfull
fusion
Comprehensive
implant portfolio
delivers solutions for a
wide range of patient
anatomies
Increased procedural
efficiencies targeting less
OR time and reduced
hospital stay
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EVOLUTION FAMILY
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ALIF EVOLUTION FAMILY
SYNCAGE® Evolution SYNFIX Evolution
• SYNFRAME® Access and Retractor
System
• Proprep
• Implant options (footprint, angle, heights)
• Implant convexities
• Evolution SQUID Inserter/Distractor
(Push blocks are system specific)
• Exposure to closure
• PEEK cages
• Anterior and anterolateral access
option
• Additional fixation required
• SYNCAGE® Evolution Trials and
Rasp
• Evolution Trial Spacer and
Implant Holder
• PEEK cage with Titanium
locking plate and screws
• Anterior access option
• Stand-alone
• SYNFIX Evolution Trials
• Aiming Device Holder
• SYNFIX Evolution Trial Implant
Holder
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TIPS AND TRICKS
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AIMING DEVICE ASSEMBLY
• The Coupling uses the same T15 drive feature as the SYNFIX Evolution Screwdriver
• The Coupling is not self retaining
• The Aiming Device cannot be assembled to the Aiming Device Holder if the Coupling is fully
inserted. Therefore make sure the Coupling is removed prior to assembling the Aiming
Device to the Holder.
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AIMING DEVICE ASSEMBLY
• It is recommended that the scrub tech removes the Coupling prior to passing the Aiming
Device Holder to the surgeon. This will minimize inadvertant release of the implant as well as
prevent impaction on the Coupling Screw.
• The Aiming Device Holder can be impacted for implant insertion. Remove the Coupling first!
• 17/19 Aiming Device is a 2 screw Aiming Device, due to the distance between the cranial and
caudal holes on the implant. Rotation of the aiming device is necessary.
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SYNFIX EVOLUTION SCREWDRIVER OPTIONS
• U-joint
• Thread Lock Sleeve (sterile, single use)
• U-joint
• Self retaining
• Straight
• Self retaining
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PROTECTION SLEEVE ASSEMBLY
• For all U-jointed SYNFIX Evolution
Instruments
• Slide the Protection sleeve, with the
arrow pointing to the handle end
• The Protection Sleeve has a pre-
angulation of 35°to facilitate insertion
into the Aiming Device and provides
additional positional memory of the
joint
35°
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THREAD LOCK SLEEVE ASSEMBLY
• Ensure the arrow on the Thread
Lock Sleeve is pointing towards the
Screwdriver handle
• Thread the Thread Lock Sleeve all the
way down on the Screwdriver tip
Note: The Thread Lock Sleeve will float freely on
the Screwdriver tip
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SCREW LOADING WITH THREAD LOCK SLEEVE
• Place a screw in the screw Loading Station with the tip down (1)
• Keep Loading Station and Screwdriver in the vertical position
• Engage the screw with the Screwdriver tip (2)
• Ensure the lobes of the Thread Lock Sleeve are mating with the loading station. It may
be necessary to advance the Sleeve using your finger to engage the screw. (2)
• Use visual aids to ensure the Thread Lock Sleeve is completetly down (3)
• Turn the Screwdriver counter-clockwise until the sleeve is fully seated on the screw
head (two-finger tight) (3)
1 2 3
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• Attach Aiming device
– Optionally detachable Aiming Device Holder
(It is recommended to have one screw inserted before detaching the holder)
• Create pilot hole with awl
• Screw insertion
– Start with the S1 screw in case of L5-S1 segment
– Align the screw with bore in aiming device
– Lobes of Thread Lock Sleeve dock and Thread Lock Sleeve automatically detaches
– Angulation of the U-Joint can make driving the screw challenging, so try and keep the
U-Joint as straight as possible.
• In case you want to remove a screw use one of the Self Retaining Screwdrivers
SCREW INSERTION
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Following complete screw insertion, the screw has to be final tightened with the Torque Limiting Handle
– Option 1 Insert the screw with a Straight Handle for ergonomics and then once all screws are
inserted switch to the Torque Limiting Handle in combination with one of the Self Retaining
Screwdrivers (1) (2)
– Option 2 Insert and final tighten the screw in one step using the Torque Limiting Handle (2)
FINAL TIGHTENING
1 2
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• During final tightening the U-joint should be as straight as possible to ensure good torque
transmission from the handle to the screw.
• Do not cross the Screwdriver over the Aiming Device Holder
• Use the Soft Tissue Retractor to retract soft tissue, so you can reduce U-joint angulation
• Use the lip designed on the Aiming Device to find solid support for the soft tissue retractor
FINAL TIGHTENING
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20°
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30°
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40°
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50°
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60°
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70°
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