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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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Next, select the "Virtual Trial" tab under "Projection".
Finally, select the profile (PL or PL40) and length (short or long) corresponding to the implant of
interest. The cylindrical overlay will show in the length of the implant that has been selected.
Note: The virtual trial cylindrical overlay does not show the specific shape of the Catalyft™ PL or
Catalyft™ PL40 implant. Instead, the cylindrical overlay is the shape of the Shaver.
Note: The Navigated Catalyft™ PL Trials should be used for final disc space sizing and implant selection.
When using the Navigated Rotating Shavers, use caution to avoid damage or disruption to the bony
endplate as this may lead to unwanted settling of the implant and/or inability to fully realize lordosis
restoration.
Helpful Hint: Keep in mind that when moving bony anatomy, it will not be detected on the Stealth
Station™ Monitor. During navigation, it is important to frequently confirm navigational accuracy by
touching the tip of the probe on known anatomical points, including accuracy checkpoints, and
comparing the position to the instrument tip in the image with its physical location. If needed, reverification will be performed before continuation of the procedure.
Navigated Posterior Rotating Shavers with Mazor
The following steps explain the use of the Catalyft™ Expandable Interbody System when used in
conjunction with the Mazor™ platform. Refer to the applicable manual listed in the “Description”
section for complete indications, warnings, precautions, and important medical information on Mazor™
and associated instruments.
Attach Navigated Rotating Shaver to NavLock™ Tracker until it is fully engaged.
On the workstation, within the NavLock tool card, select Posterior Disc Prep from the “Category”
drop down. Then select the appropriate Posterior Rotating Shaver size from the "Tip” drop down
list. The Shaver heights are available in 1mm increments from 7 to 14mm. Insert the navigated
Posterior 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 Mazor™ platform may be used to project a cylindrical overlay to
represent implant lengths.
To activate this feature, ensure both the Catalyft™ PL Inserter Tool Card and Posterior Disc Prep
Tool Card have been added to the procedure.
To visualize the virtual trial, in the "Projection" tab, click "Virtual Trial". Finally, select the profile (PL
or PL40) and length (short or long) corresponding to the implant of interest. The cylindrical overlay
will show in the length of the implant that has been selected.
™
Note: The virtual trial cylindrical overlay does not show the specific shape of the Catalyft™ PL or
Catalyft™ PL40 implant. Instead, the cylindrical overlay is the shape of the Shaver.
Note: The Navigated Catalyft™ PL Trials should be used for final disc space sizing and implant selection.
When using the Navigated Rotating Shavers, use caution to avoid damage or disruption to the bony
endplate as this may lead to unwanted settling of the implant and/or inability to fully realize lordosis
restoration.
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Navigated Trialing
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 Catalyft™ PL Navigated Trial to NavLock™ Tracker until it is fully engaged.
Ensure that the NavLock™ Tracker is positioned such that the navigation array will face the
StealthStation™ Camera and the tip of the Trial will be pointing medially when inserted.
The NavLock™ Tracker will align with either the A or B positioning designation etched on the
Catalyft™ PL Navigated Trial.
Within the NavLock™ tool card on the StealthStation™ System, choose "Catalyft™ PL Trials" as
the category.
Select the corresponding Trial from the "Tip" drop down (ex. 7mm PL Trial).
Select A or B configuration to correspond with the A/B orientation of the NavLock™ Tracker on the
Catalyft™ PL Navigated Trial.
Insert the Catalyft™ PL Navigated Trial into the disc space and advance the tip of the Trial to the
anterior apophyseal ring for maximum endplate coverage.
Select either PL or PL40 profile from the "Profile" drop down.
Note: The profile selection menu is only available when the using the PL Trials. It is not available when
using the PL40 Trials.
Select the length from the "Length" drop down menu. Green indicators shown on the Trial on the
StealthStation™ System correspond to the Short and Long implant lengths.
The Catalyft™ PL Navigated 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. To use the Slap Hammer, first remove the NavLock™ Tracker from the Catalyft™ PL
Navigated Trial.
Next, connect the Navigated Trial Adapter to the Catalyft™ PL Navigated Trial.
The Slap Hammer can now be connected to the Navigated Trial Adapter.
Note: The virtual trial size and position can be saved on the StealthStation™ and used for reference
later. To save an image of the Virtual Trial once the Trial is in place, choose the “Projection” tab; then
choose “Save Virtual Trial.”
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.
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Note: Use caution to maneuver around soft tissue upon insertion and removal of the trials, particularly
with the PL40 profile.
Navigated Trialing with Mazor
The following steps explain the use of the Catalyft™ Expandable Interbody System when used in
conjunction with the Mazor™ platform. Refer to the applicable manual listed in the “Description”
section for complete indications, warnings, precautions, and important medical information on Mazor™
and associated instruments.
Attach Catalyft™ PL Navigated Trial to NavLock™ Tracker until it is fully engaged.
Ensure that the NavLock™ Tracker is positioned such that the navigation array will face the
navigation camera and the tip of the Trial will be pointing medially when inserted.
The NavLock™ Tracker will align with either the A or B positioning designation etched on the
Catalyft™ PL Navigated Trial.
Within the NavLock™ tool card on the Mazor™ platform, choose "Catalyft™ PL Trials" as the
category.
Select the corresponding Trial from the "Tip" drop down (ex. 7mm PL Trial).
Select A or B configuration to correspond with the A/B orientation of the NavLock™ Tracker on the
Catalyft™ PL Navigated Trial.
Insert the Catalyft™ PL Navigated Trial into the disc space and advance the tip of the Trial to the
anterior apophyseal ring for maximum endplate coverage.
™
To visualize the PL or PL40 virtual trial, in the "Projection" tab, click "Virtual Trial". Select either PL
or PL40 profile from the "Profile" drop down.
Note: The profile selection menu is only available when the using the PL Trials. It is not available when
using the PL40 Trials.
Select the length from the "Length" drop down menu. Aquamarine indicators shown on the Trial on
the Mazor™ platform correspond to the Short and Long implant lengths.
The Catalyft™ PL Navigated 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. To use the Slap Hammer, first remove the NavLock™ Tracker from the Catalyft™ PL
Navigated Trial.
Next, connect the Navigated Trial Adapter to the Catalyft™ PL Navigated Trial.
The Slap Hammer can now be connected to the Navigated Trial Adapter.
Note: The virtual trial size and position can be saved on the MAZOR™ platform and used for reference
later. To save an image of the Virtual Trial once the Trail is in place, choose the “Projection” tab; then
choose “Save Projection.”
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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.
Helpful Hint: Keep in mind that when moving bony anatomy, it will not be detected on the Mazor™
Monitor. During navigation, it is important to frequently confirm navigational accuracy by touching the
tip of the probe on known anatomical points, including accuracy checkpoints, and comparing the position
to the instrument tip in the image with its physical location. If needed, re-verification will be performed
before continuation of the procedure.
Implantation
Inserter Assembly
1. Insert the Catalyft™ PL Inserter inner sleeve into the Catalyft™ PL Inserter.
2. Rotate the Catalyft™ PL Inserter Inner Sleeve clockwise until it spins freely and is firmly captured
in the Catalyft™ PL Inserter.
Note: Once fully assembled, the Catalyft™ PL Inserter Inner Sleeve should be retained in the Catalyft™
PL Inserter.
Note: Inserter assembly (Inserter, Inner Sleeve, and Driver) should be taken apart prior to cleaning and
sterilization.
Navigated Inserter Assembly and Verification
The following steps explain the use of the Catalyft™ Expandable Interbody System when used in
conjunction with the StealthStation™ System or Mazor™ platform. Refer to the applicable manual
listed in the “Description” section for complete indications, warnings, precautions, and important
medical information on StealthStation™ or Mazor™ and associated instruments.
To verify the Navigated Catalyft™ PL Inserter, thread the Catalyft™ PL Nav Verification Tool into
the shaft of the Nav Catalyft™ PL Inserter until it is fully seated. Within the Navigated Catalyft™ PL
Inserter tool card, select "Verification Tool" as the instrument tip. Place the tip of the assembly into
the Reference Frame divot. Hold perpendicular and visible to the camera until a confirmation color
is seen.
• Successful verification is indicated by a chime and a transition to green on the instrument
toolcard.
• Failed verification is indicated by a “bonk” sound and indicates that the instrument may be
positioned improperly in the divot or is bent/damaged. Inspect the instrument; if it is
bent/damaged, do not use.
• If no sound is heard when the instrument is touched to the divot, this may indicate that the
camera cannot see either the instrument or the frame.
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Important: Posterior Disc Prep instruments and Trials are verified with default instruments and not
the actual tip.
Note: To verify the Navigated Catalyft™ PL Inserter, the Verification Tool must first be selected as the
"Tip" option in the Inserter tool card.
Attach Implant to Inserter or Navigated Inserter
The following steps explain the use of the Catalyft™ Expandable Interbody System when used in
conjunction with the StealthStation™ System or Mazor™ platform. Refer to the applicable manual
listed in the “Description” section for complete indications, warnings, precautions, and important
medical information on StealthStation™ or Mazor™ and associated instruments.
Align the one-way prongs on the Catalyft™ PL Inserter or Navigated Inserter (“Inserter”) assembly
with the cut-outs on the implant.
Push the Catalyft™ PL implant onto the Inserter assembly and apply positive pressure.
Rotate the Inserter Inner Sleeve clockwise until the implant is fully seated and firmly attached to
the Inserter assembly.
Note: The implant is designed to mate with the Inserter assembly in only one orientation. The implant
should face medially when implanted. Improper orientation of the implant could cause implant or
instrument damage and may cause the implant to loosen from the Inserter assembly prematurely.
Note: DO NOT insert the Catalyft™ PL Driver into the Inserter assembly until the implant has been
inserted into the disc space.
Note: The Catalyft PL System's toxicological risk assessment was conducted for a two-implant
scenario.
Implant Positioning
With the Catalyft™ PL implant in the unexpanded (fully collapsed) position, insert the implant into
the disc space. A mallet may be used to facilitate implantation.
Advance the implant into the disc space until the leading edge of the implant aligns with the
anterior apophyseal ring of the vertebral body.
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Confirm the position of the implant with AP and Lateral fluoroscopy.
Figure 1: Catalyft™ PL or PL40 Oblique
Pl
Figure 2: Catalyft™ PL or PL40 Unilateral or
Bilateral Placement Option
acement Options
NOTE: Always implant the tallest height implant the disc space will accommodate in order to optimize
foraminal decompression and congruence of the implant and vertebral body endplates.
NOTE: Use caution to maneuver around soft tissue upon insertion of the implant, particularly with the
PL40 profile.
NOTE: The Slap Hammer can be attached to the Catalyft™ PL Inserter Inner Sleeve to aid in
repositioning or removal of the implant. Ensure the Catalyft™ PL implant is fully collapsed before
repositioning or removal.
Navigated Implant Positioning
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.
Ensure that the Navigation Tracker on the Navigated Catalyft™ PL Inserter is positioned such that
the navigation array will face the StealthStation™ Camera, and the tip of the implant faces medially
during implantation. Depress the button on the Navigated Catalyft™ PL Inserter handle to allow
the Tracker to be rotated 180º if needed. If the button is sticking, binding, or grinding, refer to the
functional inspection section of IFU for instructions regarding lubrication.
The Navigation Tracker will align with either the A or B positioning designation etched on the
Navigated Catalyft™ PL Inserter.
Note: This orientation should be the same as that used during trialing with the Catalyft™ PL Navigated
Trial.
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Within the Catalyft™ PL Inserter tool card on the StealthStation™ System, select "Catalyft™ PL" or
"Catalyft™ PL40" from the "Tip" drop down menu. This selection should correspond with the
implant.
Select A or B configuration to correspond with the A/B orientation on the Navigated Catalyft™ PL
Inserter.
Next, select the correct implant height and implant length.
With the Catalyft™ PL implant in the unexpanded (fully collapsed) position, insert the implant into
the disc space. A mallet may be used to facilitate implantation.
Advance the implant into the disc space until the leading edge of the implant aligns with the
anterior apophyseal ring of the vertebral body.
Confirm the position of the implant with the StealthStation™ System.
The Virtual Expansion feature can be used to reference the fully expanded height but does not
represent the actual expansion state of the interbody.
NOTE: When using the Navigated Catalyft™ PL Inserter, only the collapsed position of the implant is
navigated. Implant expansion is not tracked.
Note: To avoid potential navigation inaccuracy, exercise caution to prevent the application of force on
the tracker that could bias the navigated instrument. In the event of suspected inaccuracy, depress the
button and rotate tracker out of position, then return tracker to desired locked position.
NOTE: The final implant size and position can be saved on the StealthStation™ and used for reference
later. To save an image of the implant, leave the Inserter attached to the implant once placed and
choose the “Projection” tab; then choose “Save Implant.”
NOTE: Always implant the tallest height implant the disc space will accommodate in order to optimize
foraminal decompression and congruence of the implant and vertebral body endplates.
NOTE: Use caution to maneuver around soft tissue upon insertion of the implant, particularly with the
PL40 profile.
NOTE: The Slap Hammer can be attached to the Catalyft™ PL Inserter Inner Sleeve to aid in
repositioning or removal of the implant. Ensure the Catalyft™ PL implant is fully collapsed before
repositioning or removal.
NOTE: Graduated markings on the Navigated Catalyft™ PL Inserter can be used to assess the depth of
the implant in the disc space. Markings are in 1cm increments measured from the posterior aspect of
the implant when securely attached to the Navigated Catalyft™ PL Inserter.
Navigated Implant Positioning with Mazor
The following steps explain the use of the Catalyft™ Expandable Interbody System when used in
conjunction with the Mazor™ platform. Refer to the applicable manual listed in the “Description”
section for complete indications, warnings, precautions, and important medical information on Mazor™
and associated instruments.
™
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Ensure that the Navigation Tracker on the Navigated Catalyft™ PL Inserter is positioned such that
the navigation array will face the navigation camera, and the tip of the implant faces medially during
implantation. Depress the button on the Navigated Catalyft™ PL Inserter handle to allow the
Tracker to be rotated 180º if needed. If the button is sticking, binding, or grinding, refer to the
functional inspection section of IFU for instructions regarding lubrication.
The Navigation Tracker will align with either the A or B positioning designation etched on the
Navigated Catalyft™ PL Inserter.
Note: This orientation should be the same as that used during trialing with the Catalyft™ PL Navigated
Trial.
Within the Catalyft™ PL Inserter tool card on the Mazor™ platform, select "Catalyft™ PL" or
"Catalyft™ PL40" from the "Tip" drop down menu. This selection should correspond with the
implant.
Select A or B configuration to correspond with the A/B orientation on the Navigated Catalyft™ PL
Inserter.
Next, select the correct implant height and implant length.
With the Catalyft™ PL implant in the unexpanded (fully collapsed) position, insert the implant into
the disc space. A mallet may be used to facilitate implantation.
Advance the implant into the disc space until the leading edge of the implant aligns with the
anterior apophyseal ring of the vertebral body.
Confirm the position of the implant with the Mazor™ platform.
The Virtual Expansion feature can be used to reference the fully expanded height but does not
represent the actual expansion state of the interbody.
NOTE: When using the Navigated Catalyft™ PL Inserter, only the collapsed position of the implant is
navigated. Implant expansion is not tracked.
Note: To avoid potential navigation inaccuracy, exercise caution to prevent the application of force on
the tracker that could bias the navigated instrument. In the event of suspected inaccuracy, depress the
button and rotate tracker out of position, then return tracker to desired locked position.
NOTE: To save an image of the implant in the software, leave the Inserter attached to the implant once
placed and choose “Save Interbody”.
NOTE: Always implant the tallest height implant the disc space will accommodate in order to optimize
foraminal decompression and congruence of the implant and vertebral body endplates.
NOTE: Use caution to maneuver around soft tissue upon insertion of the implant, particularly with the
PL40 profile.
NOTE: The Slap Hammer can be attached to the Catalyft™ PL Inserter Inner Sleeve to aid in
repositioning or removal of the implant. Ensure the Catalyft™ PL implant is fully collapsed before
repositioning or removal.
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NOTE: Graduated markings on the Navigated Catalyft™ PL Inserter can be used to assess the depth of
the implant in the disc space. Markings are in 1cm increments measured from the posterior aspect of
the implant when securely attached to the Navigated Catalyft™ PL Inserter.
Lordotic Expansion
Insert the Catalyft™ PL Driver into the Catalyft™ PL Inserter or Navigated Inserter.
The Hex Driver tip will engage with the implant expansion mechanism.
Attach the Torque Limiting Handle to the Catalyft™ PL Driver.
Rotate the Torque Limiting Handle clockwise to expand the Catalyft™ PL implant.
Important: Do not strike the Torque Limiting Handle with a mallet which may result in damage to
the implant.
Full expansion of the Catalyft™ PL and Catalyft™ PL40 Interbody is achieved with approximately 13
half turns of the Catalyft™ PL Driver.
The laser etching visible through the expansion gauge window indicates the progress of implant
expansion.
Confirm the final implant position and expansion with AP and lateral fluoroscopy.
After the implant has been expanded the desired amount, remove the Torque Limiting Handle and
the Catalyft™ PL Driver from the Inserter assembly.
NOTE: The Catalyft™ PL implants can generate significant expansion forces during lordotic expansion.
Care should be taken to avoid endplate damage caused by excessive expansion forces. If poor bone
quality is suspected, limit the amount of lordotic expansion. Placement of the leading tip of the
Catalyft™ PL implants on the anterior apophyseal ring of the vertebral body is recommended.
NOTE: Expanding a Catalyft™ PL implant beyond the limit of the supplied Torque Limiting Handle may
result in damage to the implant and instruments and may cause injury to the patient.
Tip: The numbers 1, 2, and 3 on the Catalyft™ PL Driver can be used to help track the number of
revolutions during lordotic expansion.
Note: The Catalyft™ Expandable Interbody System is to be used with supplemental internal fixation
systems cleared for use in the lumbar spine.
Implant Positioning Special Considerations
NOTE: Always implant the tallest height implant the disc space will accommodate in order to optimize
foraminal decompression and congruence of the implant and vertebral body endplates.
It is important to maintain contact between the Catalyft™ PL implant and the vertebral body
endplates.
Excessive lordotic expansion of the Catalyft™ PL implant beyond the lordotic capability of the
motion segment could lead to a gap between the Catalyft™ PL implant and the vertebral body
endplates.
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Do not leave the Catalyft™ PL implant in place with a gap between the implant and the vertebral
body endplates. This could cause excessive subsidence and/or premature implant breakage.
If a gap is noticed after lordotic expansion of the implant, one or more of the following steps may be
considered to correct the positioning:
1. Compress the segment posteriorly and fix the position by tightening the rod into the pedicle
screw. NOTE: Bilateral facetectomy may be required for optimal posterior compression.
2. Reduce the lordotic expansion of the Catalyft™ PL implant and fix the position by tightening
the rod into the pedicle screw.
3. Remove the Catalyft™ PL implant and re-implant a taller implant (if available). Expand the
Catalyft™ PL implant to the desired lordotic expansion and fix the position by tightening the
rod into the pedicle screw.
Graft Delivery
Once the interbody device is in its final position and has been expanded to the desired height, it can
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 directly
through the Catalyft™ PL Inserter assembly.
The Graft Funnel and Graft Pusher can be used to deliver graft material through the Catalyft™ PL
Inserter or Navigated Inserter and directly into the implant.
Alternatively, the Grafton™ DBF Inject System can be used to deliver graft material. If using
Grafton™ DBF Inject System, refer to IFU.
If using Grafton™ DBF Inject, connect the Syringe to the Catalyft™ PL Inserter Inner Sleeve. After
use, remove the Grafton™ DBF Syringe from the Catalyft™ PL Inserter Inner Sleeve.
To remove the Inserter from the implant, attach the Release Handle to the Catalyft™ PL Inserter
Inner Sleeve. Rotate the Release Handle counterclockwise.
Implant Re-Positioning/Removal
To reposition or remove the Catalyft™ PL implant after the Inserter has been disconnected, first
connect the Catalyft™ PL Extractor Sleeve to the implant.
Next, pass the Graft Auger through the Catalyft™ PL Extractor Sleeve and into the Catalyft™ PL
implant. The Graft Auger can be used to clear the implant chamber and hex head of bone material
and tissue.
Remove the Graft Auger.
Insert the Catalyft™ PL Driver into the Catalyft™ PL Extractor Sleeve.
Attach the Torque Limiting Handle to the Catalyft™ PL Driver.
Rotate the Torque Limiting Handle counterclockwise to collapse the Catalyft™ PL implant.
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Important: Do not strike the Torque Limiting Handle with a mallet which may result in damage to
the implant.
After the implant is fully collapsed, remove the Torque Limiting Handle and Driver from the
Catalyft™ PL Extractor Sleeve.
Attach Slap Hammer to the Catalyft™ PL Extractor Sleeve and remove/reposition the implant as
needed.
To release the Catalyft™ PL Extractor Sleeve from the implant, attach the Release Handle to the
Catalyft™ PL Extractor Sleeve, and rotate counterclockwise.
NOTE: The blue line on the Graft Auger shaft is visible until the sharp tip of the Graft Auger passes
beyond the tip of the Catalyft™ PL Extractor Sleeve. When the blue line is no longer visible, the tip of
the Graft Auger is unprotected.
Figure
3
NOTE: The Straight Mesh Holder (905-810) may be used to grasp and reposition the implant if needed.
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