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2021
ADAPTIX INTERBODY
SYSTEM
NAVIGATED & ROBOTIC PROCEDURES
DIRECTIONS FOR USE M333023W213
MEDTRONIC
Rev. 1.0
0
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Table of Contents
Adaptix Use with StealthStation Navigation ....................................................................................... 2
Instrument Verification ............................................................................................................................. 2
Implant Size Selection with Rotating Shavers .......................................................................................... 2
Implant Size Selection with Capstone™ Trials .......................................................................................... 3
Implant Placement .................................................................................................................................... 3
Adaptix Use with Mazor Robotics ....................................................................................................... 5
Instrument Verification ............................................................................................................................. 5
Implant Size Selection with Rotating Shavers .......................................................................................... 5
Implant Size Selection with Capstone™ Trials .......................................................................................... 6
Implant Placement .................................................................................................................................... 6
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Adaptix Use with StealthStation Navigation
Instrument Verification:
Attach the Spheres to a blue Reference Frame from the Spine Referencing Set and the NavLock Trackers
from the NavLock Set. Check the Spheres to ensure they are secure. Next, attach the NavLock Trackers
to the instruments.
Place each instrument tip into the divot in the blue Reference Frame and hold perpendicular and visible
to the camera until a confirmation color is seen. Use the tracking view in the lower right of the screen to
ensure the camera is tracking the Reference Frame and instrument correctly.
To verify the Navigated TLIF/DLIF Inserter, place both prongs into the divot at once.
• Successful verification is indicated by a chime and a transition to green on the instrument tool
card.
• 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.
Helpful Hint: Assigning an instrument to a specific colored NavLock Tracker will eliminate the need to
switch the tracker from one instrument to the next instrument throughout the procedure. As an example,
the grey tracker could be assigned to the tap and the orange tracker could be assigned to the driver.
Helpful Hint: OR staff can verify instruments before the surgeon enters prior to reference frame
placement.
Important: Posterior Disc Prep instruments are verified with default instruments and not the actual tip
Implant Size Selection with Rotating Shavers:
On the StealthStation™ System, select the appropriate Rotating Shaver size from the "Tip” drop down
list. In the "Projection" tab, click "Virtual Trial" and select the appropriate implant from the "Family"
drop down list.
Helpful Hint: Ensure that the "Opacity" is set to 100% to see the projection.
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 to
approximate the starting height of the implant. Use the Virtual Trial to confirm proper placement and
alignment of the Shaver.
Important: While trialing for the implant, ensure that bone endplates stay intact. Injuring bony endplates
may lead to implant subsidence into the vertebrae.
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Important: Use caution while trialing with Shavers if poor bone quality is suspected.
Implant Size Selection with Capstone™ Trials
Capstone™ Navigated Trials are available in 8mm, 10mm, 12mm, and 14mm heights in both 22mm and
26mm lengths. If other size options are desired, use standard TLIF procedure steps using non-navigated
instruments for the trialing step.
Important: Adaptix™ implants are compatible with Capstone™ System instruments. The Adaptix™
implant is 2mm longer than the Capstone™ trials; therefore, it's important to ensure that the appropriate
implant is selected from the "Family" drop down list to view the correct projection.
On the StealthStation™ System, select the appropriate trial size from the "Tip” drop down list. In the
"Projection" tab, click "Virtual Trial" and select the appropriate implant from the "Family" drop down
list.
Helpful Hint: Ensure that the "Opacity" is set to 100% to see the projection.
Insert the Capstone™ Spinal System Navigated Trials with a NavLock™ tracker into the disc space until
the desired disc space height is established.
Select the appropriate virtual projection length to match the desired length of the implant. Confirm
proper placement and alignment of the trial from the projections shown matching the selected implant.
If needed, use a slap hammer to remove the trial
Helpful Hint: The Navigated Trials are not available for all size offerings of Adaptix™ and Capstone™
Implants.
Implant Placement:
On the StealthStation™ System, click the "Tool" tab and select the appropriate implant from the
"Family" drop down list. Select the appropriately sized implant as determined during the trialing step.
The implant can be filled with either autograft bone and/ or allograft bone graft comprised of cancellous
and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.
Place appropriate bone graft material anteriorly and contralaterally in the disc space and in the
implant's central cavity, and then firmly attach the implant to the Navigated Inserter. In the software,
choose the “Select Projection” tab, then “Show as Implant” to adjust the implant size. Implant size must
be adjusted to match selected implant. Use a mallet to gently insert the implant until it is 3mm to 4mm
below the posterior margin of the annulus.
To save an image of the implant in the software, leave the Inserter attached to the implant once placed
and choose the “Select Projection” tab; then choose “Save Implant”.
Once the implant is positioned, unthread the Inserter from the implant and remove the Inserter. Place
appropriate bone graft material into the disc space.
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Important: Ensure that the convex surfaces of the implant are aligned and in contact with the endplates
during insertion.
Important: DO NOT insert the implant sideways and rotate into final position
The Adaptix™ and Capstone ™ implants are intended to be used with supplemental posterior fixation
cleared for use in the lumbar spine.
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Adaptix Use with Mazor Robotics:
Instrument Verification:
Attach the Spheres to a blue Reference Frame from the Spine Referencing Set and the NavLock™
Trackers from the NavLock™ Set. Check the Spheres to ensure they are secure. Next, attach the
NavLock™ Trackers to the instruments.
Place each instrument tip into the divot in the robotic Reference Frame and hold perpendicular and
visible to the camera until a confirmation color is seen. Use the tracking view in the lower right of the
screen to ensure the camera is tracking the Reference Frame and instrument correctly.
To verify the Navigated TLIF/DLIF Inserter, place both prongs into the divot at once.
• 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.
Helpful Hint: Assigning an instrument to a specific colored NavLock(TM) Tracker will eliminate the need
to switch the tracker from one instrument to the next instrument throughout the procedure. As an
example, the grey tracker could be assigned to the tap and the orange tracker could be assigned to the
driver.
Helpful Hint: OR staff can verify instruments before the surgeon enters prior to reference frame
placement.
Important: Posterior Disc Prep instruments are verified with default instruments and not the actual tip.
Implant Size Selection with Rotating Shavers
On the workstation, select the appropriate Rotating Shaver size from the "Tip” drop down list. In the
"Projection" tab, click "Virtual Trial" and select the appropriate implant from the "Family" drop down
list.
Helpful Hint: Ensure that the "Opacity" is set to 100% to see the projection.
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 to
approximate the starting height of the implant.
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Use the Virtual Trial to confirm proper placement and alignment of the Shaver.
Important: While trialing for the implant, ensure that bone endplates stay intact. Injuring bony endplates
may lead to implant subsidence into the vertebrae.
Important: Use caution while trialing with Shavers if poor bone quality is suspected.
Implant Size Selection with Capstone™ Trials
Capstone™ Navigated Trials are available in 8mm, 10mm, 12mm, and 14mm heights in both 22mm and
26mm lengths. If other size options are desired, use standard TLIF procedure steps using non-navigated
instruments for the trialing step.
Important: Adaptix™ implants are compatible with Capstone™ System instruments. The Adaptix™
implant is 2mm longer than the Capstone™ trials, therefore, it's important to ensure that the appropriate
implant is selected from the "Family" drop down list to view the correct projection.
On the workstation, select the appropriate trial size from the "Tip” drop down list. In the "Projection"
tab, click "Virtual Trial" and select the appropriate implant from the "Family" drop down list.
Helpful Hint: Ensure that the "Opacity" is set to 100% to see the projection.
Insert the Capstone™ Spinal System Navigated Trials with a NavLock™ Tracker into the disc space until
the desired disc space height is established.
Select the appropriate virtual projection length to match the desired length of the implant. Confirm
proper placement and alignment of the trial from the projections shown matching the selected implant.
If needed, use a slap hammer to remove the trial.
Helpful Hint: The Navigated Trials are not available for all size offerings of Adaptix™ and Capstone™
Implants.
Implant Placement:
The implant can be filled with either autograft bone and/ or allograft bone graft comprised of cancellous
and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.
On the workstation, click the "Tool" tab and select the appropriate implant from the "Family" drop down
list. Select the appropriately sized implant as determined during the trialing step.
Place the appropriate bone graft material anteriorly and contralaterally in the disc space and in the
implant's central cavity, and then firmly attach the implant to the Navigated Inserter. In the software,
choose the “Select Projection” tab, then “Show as Implant” to adjust the implant size. Implant size must
be adjusted to match selected implant. Use a mallet to gently insert the implant until it is 3mm to 4mm
below the posterior margin of the annulus.
To save an image of the implant in the software, leave the Inserter attached to the implant once placed
and choose the “Select Projection” tab; then choose “Save Implant”.
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Once the implant is positioned, unthread the Inserter from the implant and remove the Inserter. Place
The device complies with European Directive
Consult instructions for use at this website.
the appropriate bone graft material into the disc space.
Important: Ensure that the convex surfaces of the implant are aligned and in contact with the endplates
during insertion.
Important: DO NOT insert the implant sideways and rotate into final position.
The Adaptix™ and Capstone™ implants are intended to be used with supplemental posterior fixation
cleared for use in the lumbar spine.
MDD 93/42/EEC
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