(84 days)
Not Found
No
The document describes physical intervertebral body fusion devices (spacers and cages) made of PEEK or titanium. There is no mention of software, algorithms, or any functionality that would suggest the use of AI or ML. The device description focuses solely on the physical characteristics and materials of the implants.
Yes.
The devices are indicated for intervertebral body fusion in patients with degenerative disc disease, which qualifies them as therapeutic devices.
No
This device is an intervertebral body fusion device (an implant for spinal fusion), not a diagnostic device. Its purpose is to aid in fusion and provide support, not to diagnose a condition.
No
The device description clearly details physical implants made of PEEK, titanium, and stainless steel, which are hardware components. While radiographic imaging is mentioned for visualization, the primary device is a physical intervertebral body fusion device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken 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 "implants" designed to be surgically placed in the spine. Their intended use is to aid in spinal fusion in patients with degenerative disc disease.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens from the patient. Its function is mechanical support and facilitating bone fusion within the body.
Therefore, the Stryker Spine AVS® and AccuLIF devices described are implantable medical devices, not In Vitro Diagnostic devices.
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. 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 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. 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. 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. 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.
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. The AVS® ARIA PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
The AccuLIF TL and PL Cage are indicated for intervertebral body fusion 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. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used 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.
The Stryker Spine AVS® Anchor-L is an intervertebral body fusion device 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. 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. The AVS® Anchor-L Lumbar Cage system is to be implanted via an open, anterior approach. The AVS® Anchor-L Lumbar Cage system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the AVS® Anchor-L Lumbar Cage must be used with the internal screw and plate fixation provided by AVS® Anchor-L Fixation Screws and Locking Plate. If AVS® Anchor-L is used with less than three or none of the provided screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying Locking Plate must be used anytime the device is used with any number of screws.
The Stryker Spine Aero™-AL is an intervertebral body fusion device 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. The Aero™-AL Lumbar Cage System is to be implanted via an anterior approach. The Aero™-AL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems) in addition to the included fixation anchors.
Product codes (comma separated list FDA assigned to the subject device)
OVD, 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. - AccuLIF TL and PL Cage
The AccuLIF TL and PL Expandable Lumbar Interbody Cages are crescent and rectangular-shaped titanium implants. These implants are intended for use as interbody fusion devices and are offered in a variety of lengths, footprints, and lordotic angles designed to adapt to different patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants automatically lock at 1mm increments during expansion. The implants have serrations on the superior and inferior surfaces designed for multidirectional fixation and increased surface area for osteointegration, ergonomically shaped anterior edges to facilitate cage insertion with preservation of endplates and flat posterior edges. The cages have a central opening spanning endplate to endplate for graft containment and to permit fusion through the device. The cages are manufactured from implant grade titanium alloy (Ti-6Al-4V), stainless steel (316 LVM), and silicone rubber (MED-4870). - AVS® Anchor-L Spacer
The AVS® Anchor-L Lumbar Cage System consists of a hollow, rectangular-shaped PEEK OPTIMA LT1 cage, titanium alloy (Ti-6Al-4V) bone screws, and a titanium alloy (Ti-6Al-4V) locking plate. Tantalum markers are included for visualization. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to adapt to varying patient anatomies. The AVS® Anchor-L cage consists of one closed pocket for graft containment and has serrations on the superior and inferior surfaces of the cage. The implant is designed to be used exclusively with the internal supplemental fixation provided. - Aero™-AL Lumbar Cage System
The Aero™-AL Cage is a hollow, box-shaped PEEK OPTIMA LT1 cage surrounded by a titanium alloy (Ti-6Al-4V) jacket. The PEEK cage portion consists of three closed pockets for graft containment and has serrations on the superior and inferior surfaces of the cage. The cage is designed to be used with the integrated fixation provided (Aero™-AL Fixation Anchors) in addition to supplemental fixation systems cleared for use in the lumbosacral spine. The Aero™-AL Fixation Anchors are constructed from titanium alloy (Ti-6Al-4V) and feature rails that mate with dovetail channels located within the Aero™-AL PEEK cage. Once fully seated into the channels, the anchors are designed to lock into the titanium jacket.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
L2 to S1 (vertebral levels)
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 allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients diagnosed with degenerative disc disease as defined 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, nor were any new components added to the system. Therefore, no additional testing was required or performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K093864, K093704, K083661, K100865, K101051, K141217, K120869, K133328
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2015
Stryker Corporation Garry T. Hayeck, Ph.D. Senior Regulatory Affairs Specialist Stryker Spine 2 Pearl Court Allendale, New Jersey 07401
Re: K143163
Trade/Device Name: 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, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, and Aero™-AL Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: October 31, 2014 Received: November 3, 2014
Dear Dr. Hayeck:
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
1
Page 2 - Garry T. Hayeck, Ph.D.
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 (21 CFR Part 807); labeling (21 CFR Part 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 vou 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,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K143163
Device Name AVS® AL and 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.
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)
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
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
510(k) Number (if known) K143163
Device Name AVS® PL and 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 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.
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).
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
4
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
510(k) Number (if known) K143163
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.
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
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 Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
6
510(k) Number (if known) K143163
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.
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
7
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
8
510(k) Number (if known) K143163
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.
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)
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
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 Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
9
510(k) Number (if known) K143163
Device Name AccuLIF TL and PL Cage
Indications for Use (Describe)
The AccuLIF TL and PL Cage are indicated for intervertebral body fusion 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. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion.
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
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:
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10
510(k) Number (if known) K143163
Device Name AVS® Anchor-L Spacer
Indications for Use (Describe)
The Stryker Spine AVS® Anchor-L is an intervertebral body fusion device 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. 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.
The AVS® Anchor-L Lumbar Cage system is to be implanted via an open, anterior approach.
The AVS® Anchor-L Lumbar Cage system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the AVS® Anchor-L Lumbar Cage must be used with the internal screw and plate fixation provided by AVS® Anchor-L Fixation Screws and Locking Plate. If AVS® Anchor-L is used with less than three or none of the provided screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying Locking Plate must be vice is used with any number of screws.
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
11
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
12
510(k) Number (if known) K143163
Device Name Aero™-AL Lumbar Cage System
Indications for Use (Describe)
The Stryker Spine Aero™-AL is an intervertebral body fusion device 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.
The Aero™-AL Lumbar Cage System is to be implanted via an anterior approach.
The Aero™-AL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems) in addition to the included fixation anchors.
| 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
13
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:
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14
| 510(k) Summary: Expanded Indications for Use | ||
|---|---|---|
| Stryker Spine Lumbar Intervertebral Body Fusion Devices | ||
| Submitter | Stryker Spine | |
| 2 Pearl Court | ||
| Allendale, NJ 07401 | ||
| Contact Person | Garry T. Hayeck, Ph.D. | |
| Senior Regulatory Affairs Specialist | ||
| Phone: 201-760-8043 | ||
| Fax: 201-962-4043 | ||
| E-mail: garry.hayeck@stryker.com | ||
| Date Prepared | January 22, 2015 | |
| 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
- AccuLIF TL and PL Cage
- AVS® Anchor-L Spacer
- AeroTM-AL Lumbar Cage System | |
| 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 - AccuLIF TL and PL Cage
Intervertebral fusion device with bone graft, lumbar - AVS® Anchor-L Spacer
Intervertebral fusion device with bone graft, lumbar - AeroTM-AL Lumbar Cage System
Intervertebral fusion device with integrated fixation, 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 | |
| | | 5. AVS® ARIA PEEK Spacer |
| | | Class II |
| | | 6. AccuLIF TL and PL Cage |
| | | Class II |
| | | 7. AVS® Anchor-L Spacer |
| | | Class II |
| | | 8. Aero™-AL Lumbar Cage System |
| | | Class II |
| Classification Name,
Codification | 1. | AVS® AL and AVS® ALign PEEK Spacers
Intervertebral body fusion device , 21 CFR § 888.3080 |
| | 2. | AVS® PL and AVS® UniLIF PEEK Spacers
Intervertebral body fusion device , 21 CFR § 888.3080 |
| | 3. | AVS® TL PEEK Spacer
Intervertebral body fusion device , 21 CFR § 888.3080 |
| | 4. | 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 |
| | 6. | AccuLIF TL and PL Cage
Intervertebral body fusion device , 21 CFR § 888.3080 |
| | 7. | AVS® Anchor-L Spacer
Intervertebral body fusion device , 21 CFR § 888.3080 |
| | 8. | Aero™-AL Lumbar Cage System
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 |
| | 6. | AccuLIF TL and PL Cage
MAX |
| | 7. | AVS® Anchor-L Spacer
OVD, MAX |
| | 8. | Aero™-AL Lumbar Cage System
OVD |
| Predicate Devices | | Primary Predicate:
AVS® AL and AVS® ALign PEEK Spacers (K093864) |
| | Additional Predicates: | |
| | AVS® PL and AVS® UniLIF PEEK Spacers (K093704) | |
| | AVS® TL PEEK Spacer (K083661) | |
| | AVS® Navigator PEEK Spacer (K100865) | |
| | AVS® ARIA PEEK Spacer (K101051) | |
| | AccuLIF TL and PL Cage (K141217) | |
| | AVS® Anchor-L Spacer (K120869) | |
| | Aero-AL Lumbar Cage System (K133328) | |
| 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. | |
| 6. | AccuLIF TL and PL Cage
The AccuLIF TL and PL Expandable Lumbar Interbody Cages are
crescent and rectangular-shaped titanium implants. These
implants are intended for use as interbody fusion devices and
are offered in a variety of lengths, footprints, and lordotic angles
designed to adapt to different patient anatomies. The implants
can be expanded in height after insertion in the unexpanded
state using the system instrumentation. The implants
automatically lock at 1mm increments during expansion. The
implants have serrations on the superior and inferior surfaces
designed for multidirectional fixation and increased surface
area for osteointegration, ergonomically shaped anterior edges
to facilitate cage insertion with preservation of endplates and
flat posterior edges. The cages have a central opening
spanning endplate to endplate for graft containment and to
permit fusion through the device. The cages are manufactured
from implant grade titanium alloy (Ti-6Al-4V), stainless steel (316
LVM), and silicone rubber (MED-4870). | |
| 7. | AVS® Anchor-L Spacer
The AVS® Anchor-L Lumbar Cage System consists of a hollow,
rectangular-shaped PEEK OPTIMA LT1 cage, titanium alloy (Ti-
6Al-4V) bone screws, and a titanium alloy (Ti-6Al-4V) locking
plate. Tantalum markers are included for visualization. It is
intended for use as an interbody fusion device and is offered in
a variety of heights, footprints, and lordotic angles to adapt to
varying patient anatomies. The AVS® Anchor-L cage consists of
one closed pocket for graft containment and has serrations on
the superior and inferior surfaces of the cage. The implant is
designed to be used exclusively with the internal supplemental
fixation provided. | |
| 8. | Aero™-AL Lumbar Cage System | |
| | | The Aero™-AL Cage is a hollow, box-shaped PEEK OPTIMA LT1
cage surrounded by a titanium alloy (Ti-6Al-4V) jacket. The PEEK
cage portion consists of three closed pockets for graft
containment and has serrations on the superior and inferior
surfaces of the cage. The cage is designed to be used with the
integrated fixation provided (Aero™-AL Fixation Anchors) in
addition to supplemental fixation systems cleared for use in the
lumbosacral spine. The Aero™-AL Fixation Anchors are
constructed from titanium alloy (Ti-6Al-4V) and feature rails that
mate with dovetail channels located within the Aero™-AL PEEK
cage. Once fully seated into the channels, the anchors are
designed to lock into the titanium jacket. |
| 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 f usion in patients with degenerative disc
disease (DDD) at one level or two contiquous 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 |
| | 2. | therapy.
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.
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. | |
| | 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
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. | |
| | 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 | |
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| 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. |
| 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. |
| 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. |
| The AVS® ARIA PEEK Spacers are intended to be used with |
| supplemental fixation systems that have been cleared for use in |
| the lumbosacral spine. |
| 6. AccuLIF TL and PL Cage |
| The AccuLIF TL and PL Cage are indicated for intervertebral |
| body fusion 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 |
21
of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used 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.
7. AVS® Anchor-L Spacer
The Stryker Spine AVS® Anchor-L is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone qraft 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 contiquous 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. 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.
The AVS® Anchor-L Lumbar Cage system is to be implanted via an open, anterior approach.
The AVS® Anchor-L Lumbar Caqe system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the AVS® Anchor-L Lumbar Cage must be used with the internal screw and plate fixation provided by AVS® Anchor-L Fixation Screws and Locking Plate. If AVS® Anchor-L is used with less than three or none of the provided screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying Locking Plate must be used anytime the device is used with any number of screws.
-
- Aero™-AL Lumbar Cage System The Stryker Spine Aero™-AL is an intervertebral body fusion
22
| | device 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. |
| | The AeroTM-AL Lumbar Cage System is to be implanted via an
anterior approach. |
| | The AeroTM-AL Lumbar Cage System is intended to be used with
supplemental spinal fixation systems that have been cleared for
use in the lumbosacral spine (e.g., posterior pedicle screw and
rod systems) in addition to the included fixation anchors. |
| 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 |
| | The purpose of this 510(k) submission is to seek clearance for use of |
| | allogenic bone graft comprised of cancellous and/or |
| | corticocancellous bone graft as an alternative to autogenous bone |
| | graft when the subject device is used as an adjunct to fusion. No |
| | changes have been made to the actual implants. |
| 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 allogenic bone graft comprised of cancellous and/or |
| | corticocancellous bone graft when the subject device is used as an |
| | adjunct to fusion in patients diagnosed with degenerative disc |
| | disease as defined 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, nor were any new |
| | components added to the system. Therefore, no additional 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 of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. |
| | 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. |
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