(208 days)
The Stryker Spine AVS® AL and AVS® ALign PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® AL and AVS® ALign PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® AL and AVS® ALign PEEK Spacers are to be implanted via anterior or anterolateral approach.
The AVS® AL and AVS® ALign PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
The Stryker Spine AVS® PL and AVS® UniLIF™ PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® PL and UniLIF™ PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are to be implanted via posterior approach.
The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).
The Stryker Spine AVS® TL PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally. the AVS® TL PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® TL Peek Spacers are to be implanted via posterior approach.
The AVS® TL PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).
The Stryker Spine AVS® Navigator PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® Navigator PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® Navigator PEEK Spacers are to be implanted via a posterolateral approach.
The AVS® Navigator PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
The Stryker Spine AVS® ARIA PEEK Spacers are intervertebral body fusion devices indicated for use with autograff and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® ARIA PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® ARIA PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
- AVS® AL and AVS® ALign PEEK Spacers
The AVS® AL (Anterior Large) and AVS® ALign PEEK Spacers are intended for use as interbody fusion devices. They are offered in a variety of lengths, heights and lordotic angles. The hollow, ring shaped implant has serrations on the top and bottom for fixation. The spacers are manufactured from PEEK OPTIMA LT1 and include tantalum markers for visualization. - AVS® PL and AVS® UniLIF PEEK Spacers
The AVS® Partial Lumbar (PL) PEEK Spacers and AVS® UniLIF™ PEEK Spacers are intended for use as an aid in spinal fixation. This hollow, rectangular implant is offered in a variety of lengths, heights and lordotic angles to adapt to a variety of patient anatomies. It has serrations on the superior and inferior surfaces of the implant designed to help with fixation, an ergonomically shaped anterior edge, and a flat posterior edge. Radiopaque markers have been embedded within the implant to help allow for visualization in radiographic images. The spacers are manufactured from PEEK OPTIMA LT1 and include tantalum markers for visualization. - AVS® TL PEEK Spacer
The AVS® TL PEEK Spacer is intended for use as an aid in spinal fixation. It is offered in both parallel and wedge shapes. The hollow implant has serrations on the top and bottom which are designed to help with fixation. The spacers are manufactured from PEEK OPTIMA LT1 and include tantalum markers for visualization. - AVS® Navigator PEEK Spacer
The AVS® Navigator PEEK Spacer is intended for use as an interbody fusion device. It is offered in a variety of lengths, heights and lordotic angles. The hollow implant has serrations on the top and bottom for fixation. Radiopaque markers have been embedded within the implant to help allow for visualization in radiographic images. The spacers are manufactured from PEEK OPTIMA LT1 and include tantalum markers for visualization. - AVS® ARIA PEEK Spacer
The AVS® ARIA PEEK Spacer is intended for use as an interbody fusion device. It is offered in a variety of lengths, heights and lordotic angles. The hollow, oblong-shaped implant has serrations on the top and bottom for fixation. The spacers are manufactured from PEEK OPTIMA LT1 and include tantalum markers for visualization.
This document is a 510(k) premarket notification for several intervertebral body fusion devices from Stryker Corporation. The purpose of the submission is to expand the indications for use of these devices to include patients diagnosed with degenerative scoliosis.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or a direct performance measurement for a device's ability to diagnose degenerative scoliosis. Instead, it relies on demonstrating substantial equivalence to predicate devices and leveraging existing clinical data for similar devices to support the expanded indication.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices for new indication (Degenerative Scoliosis) | "The design features, materials used, manufacturing, and sterilization methods are identical to the previously cleared Stryker Spine lumbar intervertebral body fusion devices with the exception of broadening the indications to include the use Stryker Spine lumbar intervertebral body fusion devices to treat patients diagnosed with degenerative scoliosis." |
| Expanded indication does not adversely affect system performance or represent a new worst-case scenario. | "Published clinical data for lumbar interbody fusion devices similar to the Stryker Spine lumbar intervertebral body fusion devices that are the subject of this submission was provided in support of this application. The published clinical outcomes demonstrated that the use of the lumbar interbody fusion procedures to treat patients diagnosed with degenerative scoliosis above does not adversely affect performance of the system and does not represent a new worst case scenario." |
| No additional implant testing required due to no changes to existing devices. | "No changes were made to the existing devices; therefore, no additional implant testing was required or performed." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not describe a specific "test set" in the context of an algorithm or diagnostic device. Instead, it refers to "published clinical data for lumbar interbody fusion devices similar to the Stryker Spine lumbar intervertebral body fusion devices."
- Sample Size: Not specified. The document refers generally to "published clinical data."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document as it's not a study evaluating a diagnostic algorithm. The "ground truth" for the original indication of DDD is defined as "back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies." For degenerative scoliosis, it is implied to be a clinical diagnosis, but the process of establishing this "ground truth" in the context of the referenced clinical data is not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/not provided as there is no described test set with human readers making judgments on the expanded indication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable/not provided. The submission is for an expanded indication for a physical intervertebral body fusion device, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was conducted or is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable/not provided. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the expanded indication of degenerative scoliosis, the ground truth is implied to be clinical diagnosis as established in the "published clinical data." For the original DDD indication, diagnosis is "confirmed by history and radiographic studies." The document strongly emphasizes "clinical outcomes" from the published data.
8. The sample size for the training set:
This is not applicable/not provided. There is no "training set" in the context of an AI/algorithm being developed or tested. The submission relies on existing clinical data and the equivalence of the physical devices.
9. How the ground truth for the training set was established:
This is not applicable/not provided for the same reasons as point 8.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2016
Stryker Corporation Ms. Kristen Meanv Manager, Regulatory Affairs 2 Pearl Court Allendale, New Jersey 07401
Re: K151726
Trade/Device Name: AVS® AL and AVS® ALign PEEK Spacers, AVS ® PL and AVS® UniLIFTM PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX
Dated: December 21, 2015
Received: December 22, 2015
Dear Ms. Meany:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing
{1}------------------------------------------------
(21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
K151726 Page 1 of 9
510(k) Number (if known)
Device Name
AVS® AL and AVS® ALign PEEK Spacers
Indications for Use (Describe)
The Stryker Spine AVS® AL and AVS® ALign PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® AL and AVS® ALign PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® AL and AVS® ALign PEEK Spacers are to be implanted via anterior or anterolateral approach.
The AVS® AL and AVS® ALign PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
{3}------------------------------------------------
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K151726 Page 2 of 9
Device Name AVS® PL and AVS® UniLIF™ PEEK Spacers
Indications for Use (Describe)
The Stryker Spine AVS® PL and AVS® UniLIF™ PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® PL and UniLIF™ PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are to be implanted via posterior approach.
The AVS® PL PEEK Spacers and AVS® UniLIFI™ PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
{4}------------------------------------------------
K151726 Page 3 of 9
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
{5}------------------------------------------------
K151726 Page 4 of 9
510(k) Number (if known)
Device Name AVS® TL PEEK Spacer
Indications for Use (Describe)
The Stryker Spine AVS® TL PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally. the AVS® TL PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® TL Peek Spacers are to be implanted via posterior approach.
The AVS® TL PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
{6}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
Page 5 of 9
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
{7}------------------------------------------------
K151726 Page 6 of 9
510(k) Number (if known)
Device Name AVS® Navigator PEEK Spacer
Indications for Use (Describe)
The Stryker Spine AVS® Navigator PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® Navigator PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® Navigator PEEK Spacers are to be implanted via a posterolateral approach.
The AVS® Navigator PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
{8}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
K151726 Page 7 of 9
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
{9}------------------------------------------------
K151726 Page 8 of 9
510(k) Number (if known)
Device Name AVS® ARIA PEEK Spacer
Indications for Use (Describe)
The Stryker Spine AVS® ARIA PEEK Spacers are intervertebral body fusion devices indicated for use with autograff and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® ARIA PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® ARIA PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
Type of Use (Select one or both, as applicable)
ال Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
{10}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
{11}------------------------------------------------
| 510(k) Summary: Expanded Indications for Use – Degenerative Scoliosis | ||
|---|---|---|
| Stryker Spine Lumbar Intervertebral Body Fusion Devices | ||
| Submitter | Stryker Spine2 Pearl CourtAllendale, NJ 07401 | |
| Contact Person | Kristen Meany, MS, CQA, RACManager, Regulatory AffairsPhone: 201-760-8070Fax: 201-962-4070E-mail: kristen.meany@stryker.com | |
| Date Prepared | January 15, 2016 | |
| Trade Name | 1. AVS® AL and AVS® ALign PEEK Spacers2. AVS® PL and AVS® UniLIF PEEK Spacers3. AVS® TL PEEK Spacer4. AVS® Navigator PEEK Spacer5. AVS® ARIA PEEK Spacer | |
| Common Name | 1. AVS® AL and AVS® ALign PEEK SpacersIntervertebral fusion device with bone graft, lumbar2. AVS® PL and AVS® UniLIF PEEK SpacersIntervertebral fusion device with bone graft, lumbar3. AVS® TL PEEK SpacerIntervertebral fusion device with bone graft, lumbar4. AVS® Navigator PEEK SpacerIntervertebral fusion device with bone graft, lumbar5. AVS® ARIA PEEK SpacerIntervertebral fusion device with bone graft, lumbar | |
| Proposed Class | 1. AVS® AL and AVS® ALign PEEK SpacersClass II2. AVS® PL and AVS® UniLIF PEEK SpacersClass II3. AVS® TL PEEK SpacerClass II4. AVS® Navigator PEEK SpacerClass II5. AVS® ARIA PEEK SpacerClass II | |
| Classification Name,Codification | 1. AVS® AL and AVS® ALign PEEK SpacersIntervertebral body fusion device , 21 CFR § 888.30802. AVS® PL and AVS® UniLIF PEEK SpacersIntervertebral body fusion device , 21 CFR § 888.30803. AVS® TL PEEK SpacerIntervertebral body fusion device , 21 CFR § 888.30804. AVS® Navigator PEEK Spacer | |
| Intervertebral body fusion device , 21 CFR § 888.3080 | ||
| 5. | AVS® ARIA PEEK Spacer | |
| Intervertebral body fusion device , 21 CFR § 888.3080 | ||
| Product Codes | 1. | AVS® AL and AVS® ALign PEEK SpacersMAX |
| 2. | AVS® PL and AVS® UniLIF PEEK SpacersMAX | |
| 3. | AVS® TL PEEK SpacerMAX | |
| 4. | AVS® Navigator PEEK SpacerMAX | |
| 5. | AVS® ARIA PEEK SpacerMAX | |
| Predicate Devices | Primary Predicate:AccuLIF TL and PL Cage (K143616) | |
| Additional Predicates:AVS® AL and AVS® ALign PEEK Spacers (K143163)AVS® PL and AVS® UniLIF PEEK Spacers (K143163)AVS® TL PEEK Spacer (K143163)AVS® Navigator PEEK Spacer (K143163)AVS® ARIA PEEK Spacer (K143163) | ||
| Device Description | 1. | AVS® AL and AVS® ALign PEEK SpacersThe AVS® AL (Anterior Large) and AVS® ALign PEEK Spacers areintended for use as interbody fusion devices. They are offered ina variety of lengths, heights and lordotic angles. The hollow, ringshaped implant has serrations on the top and bottom forfixation. The spacers are manufactured from PEEK OPTIMA LT1and include tantalum markers for visualization. |
| 2. | AVS® PL and AVS® UniLIF PEEK SpacersThe AVS® Partial Lumbar (PL) PEEK Spacers and AVS® UniLIF™PEEK Spacers are intended for use as an aid in spinal fixation.This hollow, rectangular implant is offered in a variety of lengths,heights and lordotic angles to adapt to a variety of patientanatomies. It has serrations on the superior and inferior surfacesof the implant designed to help with fixation, an ergonomicallyshaped anterior edge, and a flat posterior edge. Radiopaquemarkers have been embedded within the implant to help allowfor visualization in radiographic images. The spacers aremanufactured from PEEK OPTIMA LT1 and include tantalummarkers for visualization. | |
| 3. | AVS® TL PEEK Spacer | |
| The AVS® TL PEEK Spacer is intended for use as an aid in spinal fixation. It is offered in both parallel and wedge shapes. The hollow implant has serrations on the top and bottom which are designed to help with fixation. The spacers are manufactured from PEEK OPTIMA LT1 and include tantalum markers for visualization. | ||
| 4. AVS® Navigator PEEK Spacer The AVS® Navigator PEEK Spacer is intended for use as an interbody fusion device. It is offered in a variety of lengths, heights and lordotic angles. The hollow implant has serrations on the top and bottom for fixation. Radiopaque markers have been embedded within the implant to help allow for visualization in radiographic images. The spacers are manufactured from PEEK OPTIMA LT1 and include tantalum markers for visualization. | ||
| 5. AVS® ARIA PEEK Spacer The AVS® ARIA PEEK Spacer is intended for use as an interbody fusion device. It is offered in a variety of lengths, heights and lordotic angles. The hollow, oblong-shaped implant has serrations on the top and bottom for fixation. The spacers are manufactured from PEEK OPTIMA LT1 and include tantalum markers for visualization. | ||
| Indications for Use | 1. AVS® AL and AVS® ALign PEEK Spacers The Stryker Spine AVS® AL and AVS® ALign PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. | |
| DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. | ||
| Additionally, the AVS® AL and AVS® Align PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. |
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| The AVS® AL and AVS® ALign PEEK Spacers are to be implanted | |
|---|---|
| via anterior or anterolateral approach. | |
| The AVS® AL and AVS® ALign PEEK Spacers are intended to beused with supplemental fixation systems that have been clearedfor use in the lumbosacral spine. | |
| 2. | AVS® PL and AVS® UniLIF PEEK SpacersThe Stryker Spine AVS® PL and AVS® UniLIF™ PEEK Spacers areintervertebral body fusion devices indicated for use withautograft and/or allogenic bone graft comprised of cancellousand/or corticocancellous bone graft when the subject device isused as an adjunct to fusion in patients with degenerative discdisease (DDD) at one level or two contiguous levels from L2 toS1. |
| DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies. The DDD patients may also have up to Grade Ispondylolisthesis at the involved level(s). These patients shouldbe skeletally mature and have six months of nonoperativetherapy. | |
| Additionally, the AVS® PL and UniLIF™ PEEK Spacers can beused as an adjunct to fusion in patients diagnosed withdegenerative scoliosis. | |
| The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers areto be implanted via posterior approach. | |
| The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers areintended to be used with supplemental spinal fixation systemsthat have been cleared for use in the lumbosacral spine (i.e.,posterior pedicle screw and rod systems). | |
| 3. | AVS® TL PEEK SpacerThe Stryker Spine AVS® TL PEEK Spacers are intervertebral bodyfusion devices indicated for use with autograft and/or allogenicbone graft comprised of cancellous and/or corticocancellousbone graft when the subject device is used as an adjunct tofusion in patients with degenerative disc disease (DDD) at onelevel or two contiguous levels from L2 to S1. |
| DDD is defined as back pain of discogenic origin with |
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| degeneration of the disc confirmed by history and radiographicstudies. The DDD patients may also have up to Grade Ispondylolisthesis at the involved level(s). These patients shouldbe skeletally mature and have six months of nonoperativetherapy.Additionally, the AVS® TL PEEK Spacers can be used as anadjunct to fusion in patients diagnosed with degenerativescoliosis.The AVS® TL PEEK Spacers are to be implanted via posteriorapproach. |
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| The AVS® TL PEEK Spacers are intended to be used withsupplemental fixation systems that have been cleared for use inthe lumbosacral spine (i.e., posterior pedicle screw and rodsystems). |
| 4. |
| AVS® Navigator PEEK SpacerThe Stryker Spine AVS® Navigator PEEK Spacers areintervertebral body fusion devices indicated for use withautograft and/or allogenic bone graft comprised of cancellousand/or corticocancellous bone graft when the subject device isused as an adjunct to fusion in patients with degenerative discdisease (DDD) at one level or two contiguous levels from L2 toS1. |
| DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies. The DDD patients may also have up to Grade Ispondylolisthesis at the involved level(s). These patients shouldbe skeletally mature and have six months of nonoperativetherapy. |
| Additionally, the AVS® Navigator PEEK Spacers can be used asan adjunct to fusion in patients diagnosed with degenerativescoliosis. |
| The AVS® Navigator PEEK Spacers are to be implanted via aposterior or posterolateral approach. |
| The AVS® Navigator PEEK Spacers are intended to be used withsupplemental fixation systems that have been cleared for use inthe lumbosacral spine. |
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| 5. AVS® ARIA PEEK SpacerThe Stryker Spine AVS® ARIA PEEK Spacers are intervertebralbody fusion devices indicated for use with autograft and/orallogenic bone graft comprised of cancellous and/orcorticocancellous bone graft when the subject device is usedas an adjunct to fusion in patients with degenerative discdisease (DDD) at one level or two contiguous levels from L2 toS1. | |
|---|---|
| DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies. The DDD patients may also have up to Grade Ispondylolisthesis at the involved level(s). These patients shouldbe skeletally mature and have six months of nonoperativetherapy. | |
| Additionally, the AVS® ARIA PEEK Spacers can be used as anadjunct to fusion in patients diagnosed with degenerativescoliosis. | |
| The AVS® ARIA PEEK Spacers are intended to be used withsupplemental fixation systems that have been cleared for use inthe lumbosacral spine. | |
| Summary ofTechnologicalCharacteristics | The subject Stryker Spine lumbar intervertebral body fusion devicesand the predicate systems share similar design features:• Graft windows for packing autogenous and/or allogenic bonegraft comprised of cancellous and/or corticocancellous bone graftwhen the subject device is used as an adjunct to fusion• Serrations on the superior and inferior surfaces• Comparable heights, widths, depths, and lordotic angles |
| Summary of thePerformance Data | Published clinical data for lumbar interbody fusion devices similar tothe Stryker Spine lumbar intervertebral body fusion devices that arethe subject of this submission was provided in support of thisapplication. The published clinical outcomes demonstrated that theuse of the lumbar interbody fusion procedures to treat patientsdiagnosed with degenerative scoliosis above does not adverselyaffect performance of the system and does not represent a newworst case scenario. No changes were made to the existing |
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| devices; therefore, no additional implant testing was required or | |
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| performed. | |
| Conclusion | The design features, materials used, manufacturing, and sterilizationmethods are identical to the previously cleared Stryker Spine lumbarintervertebral body fusion devices with the exception of broadeningthe indications to include the use Stryker Spine lumbar intervertebralbody fusion devices to treat patients diagnosed with degenerativescoliosis. |
| The data presented in this submission demonstrate that the StrykerSpine lumbar intervertebral body fusion devices that are the subjectof this submission with the broadened indications as describedabove are substantially equivalent to the predicate systems. |
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.