(208 days)
Not Found
No
The device description and intended use focus solely on the physical characteristics and function of intervertebral body fusion devices made of PEEK, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is an intervertebral body fusion device indicated for use in patients with degenerative disc disease and degenerative scoliosis, which means it is used to treat or manage a medical condition.
No
The device is an intervertebral body fusion device (spacer), indicated for use in spinal fusion surgery to treat degenerative disc disease and degenerative scoliosis. It is an implantable medical device used for treatment, not for diagnosing conditions.
No
The device description clearly states that the devices are physical implants made from PEEK material with tantalum markers, which are hardware components.
Based on the provided information, the Stryker Spine AVS® PEEK Spacers are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that these are "intervertebral body fusion devices" and their intended use is for "adjunct to fusion in patients with degenerative disc disease (DDD)" and "degenerative scoliosis." They are physical implants designed to be placed within the body during surgery.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device itself is implanted.
Therefore, these devices fall under the category of implantable medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
MAX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic images
Anatomical Site
L2 to S1 (lumbosacral spine)
Indicated Patient Age Range
Skeletally mature
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 changes were made to the existing devices; therefore, no additional implant testing was required or performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 Spine | |
| 2 Pearl Court | ||
| Allendale, NJ 07401 | ||
| Contact Person | Kristen Meany, MS, CQA, RAC | |
| Manager, Regulatory Affairs | ||
| Phone: 201-760-8070 | ||
| Fax: 201-962-4070 | ||
| E-mail: kristen.meany@stryker.com | ||
| Date Prepared | January 15, 2016 | |
| Trade Name | 1. AVS® AL and AVS® ALign PEEK Spacers |
- AVS® PL and AVS® UniLIF PEEK Spacers
- AVS® TL PEEK Spacer
- AVS® Navigator PEEK Spacer
- AVS® ARIA PEEK Spacer | |
| Common Name | 1. AVS® AL and AVS® ALign PEEK Spacers
Intervertebral fusion device with bone graft, lumbar - AVS® PL and AVS® UniLIF PEEK Spacers
Intervertebral fusion device with bone graft, lumbar - AVS® TL PEEK Spacer
Intervertebral fusion device with bone graft, lumbar - AVS® Navigator PEEK Spacer
Intervertebral fusion device with bone graft, lumbar - AVS® ARIA PEEK Spacer
Intervertebral fusion device with bone graft, lumbar | |
| Proposed Class | 1. AVS® AL and AVS® ALign PEEK Spacers
Class II - AVS® PL and AVS® UniLIF PEEK Spacers
Class II - AVS® TL PEEK Spacer
Class II - AVS® Navigator PEEK Spacer
Class II - AVS® ARIA PEEK Spacer
Class II | |
| Classification Name,
Codification | 1. AVS® AL and AVS® ALign PEEK Spacers
Intervertebral body fusion device , 21 CFR § 888.3080 - AVS® PL and AVS® UniLIF PEEK Spacers
Intervertebral body fusion device , 21 CFR § 888.3080 - AVS® TL PEEK Spacer
Intervertebral body fusion device , 21 CFR § 888.3080 - 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 Spacers
MAX |
| | 2. | AVS® PL and AVS® UniLIF PEEK Spacers
MAX |
| | 3. | AVS® TL PEEK Spacer
MAX |
| | 4. | AVS® Navigator PEEK Spacer
MAX |
| | 5. | AVS® ARIA PEEK Spacer
MAX |
| 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 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. |
| | 2. | 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. |
| | 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 be | |
| used with supplemental fixation systems that have been cleared | |
| for use in the lumbosacral spine. | |
| 2. | AVS® PL and AVS® UniLIF PEEK Spacers |
| 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 | |
| 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® 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). | |
| 3. | AVS® TL PEEK Spacer |
| 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 |
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| 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). |
| 4. |
| AVS® Navigator PEEK Spacer |
| 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 |
| posterior or 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. |
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| | 5. AVS® ARIA PEEK Spacer
The Stryker Spine AVS® ARIA 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® 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. |
| Summary of
Technological
Characteristics | The subject Stryker Spine lumbar intervertebral body fusion devices
and the predicate systems share similar design features:
• Graft windows for packing autogenous and/or allogenic bone
graft comprised of cancellous and/or corticocancellous bone graft
when 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 the
Performance Data | 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 changes were made to the existing |
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| devices; therefore, no additional implant testing was required or | |
|---|---|
| performed. | |
| Conclusion | 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. | |
| The data presented in this submission demonstrate that the Stryker | |
| Spine lumbar intervertebral body fusion devices that are the subject | |
| of this submission with the broadened indications as described | |
| above are substantially equivalent to the predicate systems. |