(30 days)
Not Found
No
The document describes a physical intervertebral body fusion device and its modifications, with no mention of software, algorithms, or AI/ML capabilities.
Yes
This device is an intervertebral body fusion device used to treat degenerative disc disease by promoting bone fusion and providing support, which are therapeutic actions.
No
This device is an intervertebral body fusion device (spacer) used for surgical implantation, not for diagnosis.
No
The device description clearly states it is a "Hollow frame PEEK Implant" and describes physical modifications to the implant, indicating it is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "intervertebral body fusion device indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD)". This describes a surgical implant used to treat a physical condition within the body.
- Device Description: The description details the physical characteristics of the implant (hollow frame PEEK implant, fenestrations, serrations, etc.) and its intended use in a surgical procedure (implanted via posterior approach, used with supplemental spinal fixation systems).
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided text does not mention any testing of samples or diagnostic purposes.
The device is a surgical implant used for spinal fusion, which is a therapeutic procedure, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Stryker Spine AVS PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft 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 are to be implanted via posterior approach.
The AVS PL 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).
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The subject AVST™ PL PEEK Spacers are implantable devices designed for intervertebral body fusion. They are characterized by a hollow frame made of PEEK material, lateral fenestrations, and serrations on their superior and inferior surfaces. The line extension introduces modifications to previously approved AVSTM PL PEEK Spacers (under K073470, K080758, and K082014) to include a range of 0° and 4° spacers in heights from 6-13mm, and lengths of 30 and 33mm with an 11mm width. Specific modifications include replacing the ogival shaped nose with a wedge-shaped design to facilitate insertion, removing the threaded hole on the front side, adapting the back side threaded hole in smaller heights to be consistent with existing instruments, and tapering the back side in the frontal plane to match vertebral endplate geometry while increasing the size of the two flat surfaces for improved connection with inserters. These spacers may also be referred to as AVS™M Plus or UniLIF.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
from 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)
Testing in compliance with FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the AVS PL PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems.
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.
K073470, K080758, K082014, P960025
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.
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K090816 Page 1 of 3
AVSTM PL PEEK Spacer System, Line Extension
Special 510(k) Premarket Notification
Special 510(k) Summary of Safety and Effectiveness:
Modifications to the AVS™ PL PEEK Spacer System
| Proprietary Name: | AVST™ PL PEEK Spacer System | APR 24 2005 |
|---|---|---|
| Common Name: | Spinal Fixation Appliances | |
| Proposed Regulatory Class: | Class II | |
| Interevertebral body fusion device | ||
| 21 CFR 888.3080 | ||
| Device Product Code: | MAX | |
| For Information contact: | Vikki M. O'Connor | |
| Regulatory Affairs Project Manager | ||
| 2 Pearl Court | ||
| Allendale, NJ 07401 | ||
| Telephone: (201) 760-8215 | ||
| Fax: (201) 760-8415 | ||
| Email: Vikki.O'Connor@Stryker.com | ||
| Date Summary Prepared: | March 18, 2009 | |
| Predicate Device | AVST™ PL PEEK Spacers (K073470, K080758 and K082014) | |
| DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP Spine | ||
| System: P960025 (i.e., Brantigan Cage) | ||
| Predicate Device Information | The subject AVST™ PL PEEK Spacers and the predicates | |
| AVST™ PL PEEK Spacers and DePuy's Lumbar I/F Cage (i.e., | ||
| Brantigan Cage) share similar design features: | ||
| • Hollow frame PEEK Implant | ||
| • Lateral fenestrations | ||
| • Serrations on the superior and inferior surfaces |
1
K090816 Page 2 of 3
AVSTM PL PEEK Spacer System, Line Extension
Special 510(k) Premarket Notification
- · Comparable heights, widths, and angles
- · Materials and mechanical testing results are similar between the subject device and the listed predicates.
This Special 510(k) premarket notification is intended to introduce the following modifications to the AVSTM PL PEEK Spacers approved under K073470, K080758, and K082014:
A range of 0° and 4° AVSTM PL PEEK Spacers (6-13mm in height, 30 and 33mm lengths with an 11mm width) were found to be substantially equivalent to the Brantigan Cage in K073470. In K080758, minor design changes were introduced to the 0° degree spacers. K082014 added four (4) implants in a 14 mm height. The minor design modifications approved under K080758 had been incorporated in these 14 mm implants.
The AVSTM PL PEEK Spacers that are the subject of this application add the design modifications that were approved on the 0 ° implants under K080758, to the 4 ° implants previously approved under K073470 and K082014. The lengths, width, and angles are the same as the predicate AVS® PL PEEK Spacers previously approved. The modifications include replacing the ogival shaped nose of the implant with the wedge-shaped design to facilitate insertion of the spacer between adjacent vertebral endplates. The threaded hole on the front side was removed as it is not needed to retrieve the implant and field feedback has confirmed that it would likely not be used. In the smaller heights, the back side threaded hole has been adapted to the various heights of the spacers to remain consistent with the existing instruments (i.e., the two Inserters), and the back side of the spacer has been tapered in the frontal plane to match
Description of Device Modification
2
K090816
AVSTM PL PEEK Spacer System, Line Extension
Special 510(k) Premarket Notification
the geometry of the vertebral endplates and the size of the two flat surfaces has been increased to improve the connection with the Inserters.
Note that the AVS™ PL PEEK Spacers may also be referred to as AVS™M Plus or UniLIF.
The Stryker Spine AVS™ PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft 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 are to be implanted via posterior approach.
The AVSTM PL 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).
Testing in compliance with FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the AVS PL PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems.
Intended Use
Summary of the Technological Characteristics
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the left side of the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Corporation % Ms. Vikki M. O'Connor Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
APR 2 4 2009
Re: K090816
Trade/Device Name: Stryker Spine AVS PL PEEK Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Product March 23, 2009 Received: March 25, 2009
Dear Ms. O'Connor:
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 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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.
4
Page 2- Ms. Vikki M. O'Connor
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K_090 8 / طا
Device Name: Stryker Spine AVS PL PEEK Spacers
Indications For Use:
The Stryker Spine AVS PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft 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 are to be implanted via posterior approach.
The AVS PL 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).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
neral, Restorative, and Neurological Devices
510(k) Number K090811