2021
Catalyft™ PL
Expandable Interbody
System
DIRECTIONS FOR USE M333023W217 Rev. 2.0
MEDTRONIC
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Contents
Purpose .................................................................................................................................................... 3
Description .............................................................................................................................................. 3
Navigation Technology Set-Up ................................................................................................................. 4
Robotic Technology Set-Up ...................................................................................................................... 4
Site Access and Disc Preparation .............................................................................................................. 4
Trialing .......................................................................................................................................................... 5
Standard Trialing ..................................................................................................................................... 5
Navigated Posterior Rotating Shavers.................................................................................................. 5
Navigated Posterior Rotating Shavers with Mazor™ .......................................................................... 6
Navigated Trialing ................................................................................................................................... 7
Navigated Trialing with Mazor™ ............................................................................................................ 8
Implantation ................................................................................................................................................ 9
Inserter Assembly ................................................................................................................................... 9
Navigated Inserter Assembly and Verification ..................................................................................... 9
Attach Implant to Inserter or Navigated Inserter .............................................................................. 10
Implant Positioning ............................................................................................................................... 10
Navigated Implant Positioning ............................................................................................................. 11
Navigated Implant Positioning with Mazor™...................................................................................... 12
Lordotic Expansion ............................................................................................................................... 14
Implant Positioning Special Considerations ....................................................................................... 14
Graft Delivery .......................................................................................................................................... 15
Implant Re-Positioning/Removal ........................................................................................................ 15
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Purpose
The Catalyft™ PL Expandable Interbody System is a fusion device intended for stabilization and to
promote bone fusion during the normal healing process following surgical correction of disorders
of the spine. The product should be implanted only by a physician thoroughly knowledgeable in the
implant's material and surgical aspects and instructed as to its mechanical and material
applications and limitations.
Description
The Catalyft™ PL Expandable Interbody System is an expandable titanium alloy interbody device
consisting of expandable interbodies of various widths, lengths, heights, and lordotic angles to
accommodate patient anatomy. These devices can be inserted between two lumbar or
lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion
surgeries. Implants have a central cavity that allows them to be packed 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.
No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a
particular purpose or use are specifically excluded.
Please see the package insert for the complete list of indications, warnings, precautions, and other
important medical information.
Consult instructions for use included with the product and/or at this website
www.medtronic.com/manuals.
Catalyft™ PL Expandable Interbody System (eManual M333023W048E)
Catalyft™ PL Expandable Interbody System- EU only (eManual M333023W048EU)
Other devices referenced in this document:
StealthStation™ S8 System Manual (Manual Document Number: 9735573)
StealthStation™ S7 System Manual (Manual Document Number: 9733782)
Navlock™ Tracker (Manual Document Number: 9734289)
NOTE: Additional instructions included in the applicable navigated instruments IFU/eManual
referenced above
O-arm® Imaging System User Manual (Manual Document Number: BI-500-00060)
Grafton DBF Inject
Mazor X Stealth™ Edition User Manual (Manual Document Number: TSD0114-01 (US) or TSD0115
(EU)
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Navigation Technology Set-Up
For a navigated surgery, the OR should be equipped with the O-arm™ Image Acquisition System,
the Mobile Viewing Station (MVS), and the StealthStation™ S7 or S8 System. Consult the
StealthStation™ System and O-arm™ Imaging System manuals for complete indications,
warnings, precautions, important medical information, and instruction on equipment and OR setup, reference frame placement, registration, and StealthStation™ Spine Software Workflow such
as correct procedure selection, instrument verification, and image acquisition.
Important: Ensure the Reference Frame is properly secured to anatomy. Neglecting to verify that
the Reference Frame is secured could result in navigational inaccuracy if the hardware moves in
relation to the anatomy after registration is complete.
Robotic Technology Set-Up
For a Mazor™ surgery, the OR should be equipped with the O-arm™ Image Acquisition System
including the Mobile Viewing Station (MVS), or a compatible C-arm (a 12-inch C-arm is
recommended over a 9-inch C-arm to register larger anatomical segments), and the Mazor ™
platform. Consult the Mazor™ and O-arm™ Imaging System manuals for complete indications,
warnings, precautions, important medical information, and instruction on equipment and OR setup, reference frame placement, registration, and Mazor™ procedural workflow such as correct
procedure selection, instrument verification, and image acquisition.
The navigation camera should be positioned at the head end of the patient table so that the camera
has an unobstructed line-of-sight to the Robotic Reference Frame.
Site Access and Disc Preparation
Perform surgical site access and disc preparation per the surgeon’s usual manner. The main goal is
to remove extruded fragments, decompress neural elements, and provide entry into the disc space
for distraction, with minimal or no nerve root retraction.
Note: Patient must be properly positioned and/or stabilized during surgery, per the surgeon’s chosen
approach.
To ensure proper fusion below and around the location of the fusion, autogenous bone and/or
allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or
demineralized allograft bone with bone marrow aspirate must be used. Pre-pack the disc space per
the surgeon’s usual manner, taking into consideration patient specific needs.
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Trialing
The Catalyft™ PL Trials or Navigated Trials (“Trials”) can be used to determine the desired profile,
length, starting height, and position of the implant.
Trials are available in both the Catalyft™ PL and Catalyft™ PL40 profiles.
Trials are available in 7mm, 9mm, and 11mm heights which correspond to the available implant
heights of 7mm, 9mm, and 11mm.
Radiographic features on the Trial are intended to assist in the selection of the desired length,
position, and orientation of the implant within the disc space when used with intra-operative
fluoroscopy.
Standard Trialing
Insert the Trial into the disc space and advance the tip of the Trial to the anterior apophyseal ring
for maximum endplate coverage.
Confirm the size and position of the Trial using fluoroscopy.
The Trial should fit snugly into the disc space. Select a taller Trial height to achieve the desired fit if
needed.
The Slap Hammer can be attached to the Trial to help remove the Trial from the disc space after
trialing.
Note: It is recommended to begin the trialing sequence with the 7mm Trial to avoid injury to the bony
endplates. Increase Trial height from 7mm to 9mm to 11mm as needed to achieve the desired fit.
Note: Use caution to maneuver around soft tissue upon insertion and removal of the trials, particularly
with the PL40 profile.
Navigated Posterior Rotating Shavers
The following steps explain the use of the Catalyft™ Expandable Interbody System when used in
conjunction with the StealthStation™ System. Refer to the applicable manual listed in the
“Description” section for complete indications, warnings, precautions, and important medical
information on StealthStation™ and associated instruments.
Attach Navigated Rotating Shaver to NavLock™ Tracker until it is fully engaged.
On the StealthStation™ System, choose the “Tool” tab to select an appropriately sized Navigated
Rotating Shaver. The Navigated Rotating Shaver heights are available in 1mm increments from 7 to
14mm. Insert the Navigated Rotating Shaver into the disc space in the direction parallel to the
endplates, and progressively increase Shaver sizes from small to large using tactile feedback during
rotation.
The Virtual Trial feature on the StealthStation™ System may be used to project a cylindrical
overlay to represent implant lengths.
To activate this feature, select both Catalyft™ PL Inserter Tool Card and Posterior Disc Prep Tool
Card.
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