Medtronic 981000002 Instructions for Use

SURGICAL TECHNIQUE
Catalyft™ LS
Expandable Interbody System
Table of contents
1 Implant overview
2 Instrument overview
4 Access
5 Templates/Distractors
6 Cage attachment
7 Pre-implantation graft delivery
8 Cage insertion
9 Cage expansion
11 Gr a f t o n™ DBF post-expansion filling the cage
12 Screw fixation
16 Posterior fixation/posterior access to expansion mechanism
17 Explantation
18 Product ordering information
19 Important product information
2
Cage overview
pansion measurements
Ex
Anterior
height
Size Expansion
S 06
S 10
M 06
M 10
L 06
L10
Min. 6 10 9
Max. 11. 5 18 30
Min. 10 14 9
Max. 15.5 22 30
Min. 6 10 8
Max. 11.5 19.5 29
Min. 10 14 8
Max. 15.5 23.5 29
Min. 6 10 7
Max. 11.5 21 29
Min. 10 14 7
Max. 15.5 24.5 29
Lordosis angle
Posterior height (mm)
Anterior height (mm)
Posterior
height
Lordosis angle (degrees)
6mm
edium
M
10mm
Medium
10 –19mm
14–23mm
7-29°
6–11mm
7-29°
10–15mm
Max achievable lordosis angle is pending height expansion
Footrints
Small
32mm × 25mm
Medium
37mm × 29mm
Screw overview
• Lengths: 25-55mm
• Inner diameter: 3.7mm
• Outer diameter: 5.5mm
• Cancellous thread pitch: 3.2mm
• Cortical thread pitch: 1.6mm
• Self-drilling and self-tapping screws
If the posterior aspect of the cage is at max expansion, the greatest possible lordosis would be 14° for the Small cage, 15.5° for the Medium, and 16° for the Large cage.
Large
42mm × 32mm
Cortical thread
Cancellous thread
• Dual thread design
1
Instrument overview
Templates
Anterior Large
981000027
*
Anterior Medium
981000025
Anterior Small
981000023
*Templates mimic corresponding cage at collapsed state.
Bone Screw Instrumentation
Angled
Drill
98100032
Angled
T25 Screwdriver
981000030
Short
T25 Screwdriver
981000031
Distractors
Anterior Large
981000028
Anterior Medium
981000026
Anterior Small
981000024
T25 Screwdriver
2150100
2
QC Palm Handle
G1700 59
CATA LYFT™ LS EXPANDABLE INTERBODY DEVICE | INSTRUMENT OVERVIEW
Inserter and Inner Shafts
Inserter
981000001
Lordosis/Parallel Shaft
5Nm
981000002
Bone Graft
Loader
981000040
Lordosis/Parallel
Shaft* 6Nm
981000006
Syringe Adapter
981000041
Lordosis/Parallel Shaft*
7Nm
981000007
*Optional expansion shafts
Slaphammer
215114 0
Anterior/Posterior*
Shaft
981000003
3
Access
Catalyft™ LS expandable
The interbody system can be used with an OLIF51™ procedure or an ALIF procedure, depending upon the surgeon’s preference and anatomical considerations. Refer to the appropriate procedural surgical technique for access and disc preparation instructions.
ALIF
procedure
OLIF51™
procedure
4
Templates/Distractors
After the disc space has been prepared and any osteophytes have been removed, Templates matching the cage in a collapsed state are used to identify the cage's footprint and size matching the initial anatomy.
Distractors can be used sequentially to stretch the soft tissues and optimize the segmental correction by expansion of the cage in situ. A/P and lateral fluoroscopy can also be used to confirm the appropriate cage size and positioning.
Note
Due to expansion capability of the cage, the template may fit loosely in the disc space.
Temp
late
Dist
ractor
5
Cage attachment
After the appropriate cage has been determined, attach the corresponding cage to the Inserter. Insert the Lordosis/Parallel Shaft 5NM 98100002 into the Inserter by pressing down on the release button on the handle and fully inserting the shaft into the cannula of the Inserter until the expansion indicator is in the "Parallel" expansion state. Attach the cage to the Inserter by threading the Inserter into the female thread of the cage by using the thumbwheel on the Inserter and advancing the threads until the cage is firmly attached to the cage. When inserting the cage, the Inserter should be in the parallel expansion state.
Note
The Inserter can be attached independently of the orientation of the cage or handle.
Ensure the cage is in collapsed state prior to implantation.
6
Pre-implantation graft delivery
Once the correct cage has been attached to the Inserter, the Bone Graft Loader can be used to pre-pack the cage with autogenous bone graft and/ or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. If using Grafton™ DBF Inject, hydrate the DBF with BMA according to the mixing instructions in the Grafton™ DBF Inject instructions for use.
Note
Refer to the Grafton™ DBF Inject IFU for handling and preparation steps.
Graft volume guidelines
Part number Description
981023322 Small 06 0.7cc
981023325 Small 10 1.1cc
981025522 Medium 06 1.2cc
981025525 Medium 10 1.8cc
981027722 Large 06 1.7c c
981027725 Large 10 2.5cc
Pre-pack lateral windows
7
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