(79 days)
K073470, P960025
Not Found
No
The summary describes a physical implant (spacer) and its intended use, materials, and dimensions. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
This device is an intervertebral body fusion device used to treat degenerative disc disease, which involves repairing damaged tissue and restoring function, falling under the definition of a therapeutic device.
No
Explanation: The device is an intervertebral body fusion device (spacer) used for spinal fixation, not for diagnosing conditions. It is implanted to aid in spinal fusion after a diagnosis of degenerative disc disease has already been made.
No
The device description clearly states it is a physical implant (intervertebral body fusion device) made of PEEK with Tantalum marker pins, not software.
No, 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Stryker Spine AVS® TL PEEK Spacers are implants designed to be surgically placed within the body to aid in spinal fusion.
- Intended Use: The intended use is to provide structural support and facilitate bone fusion in patients with degenerative disc disease. This is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
The information provided clearly describes a surgical implant used for treatment, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Stryker Spine AVS® TL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft bone 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 Spacers are to be implanted via posterior approach.
The AVS® TL 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
MAX
Device Description
The AVS® TL Peek Spacers are intervertebral body fusion devices intended for use as an aid in spinal fixation. The Stryker Spine AVS® TL PEEK Spacer is a "banana" shaped, hollow frame implant with lateral fenestrations. The spacers incorporate three (3) Tantalum marker pins to aid in radiographic visualization.
The Stryker Spine AVS® TL PEEK Spacer is available in a variety of sizes, from 7 mm to 18mm in height, two (2) lengths: 25 mm and 30 mm and one (1) width: 9 mm. There are also 0° parallel and 4° wedge shaped options, which allows the surgeon to best choose the size suited to the patient's anatomy and pathology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (of the 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
Testing in compliance with FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the AVS® TL PEEK Spacers and demonstrated substantial equivalent performance characteristics to the identified predicate device systems.
Key Metrics
Not Found
Predicate Device(s)
K073470, P960025
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
Stryker Spine AVS® TL PEEK Spacers
Traditional 510(k) Premarket Notification
FEB ஓ 7 2009
510(k) Summary: AVS® TL PEEK Spacers
| Submitter: | Stryker Spine
2 Pearl Court
Allendale, New Jersey 07401 |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ms. Kimberly Lane
Regulatory Affairs Specialist
Phone: 201-760-8215
FAX: 201-760-8415
Email: kimberly.lane@stryker.com |
| Date Prepared | December 9, 2008 |
| Trade Name | Stryker Spine AVS® TL PEEK Spacers |
| Proposed Class | Class II |
| Classification Name
and Number | Intervertebral body fusion device, 21 CFR 888.3080 |
| Product Code | MAX |
| Predicate Devices | Stryker Spine AVS® PL PEEK Spacers: K073470
DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP Spine
System: P960025. |
| Device Description | The AVS® TL Peek Spacers are intervertebral body fusion
devices intended for use as an aid in spinal fixation. The Stryker
Spine AVS® TL PEEK Spacer is a "banana" shaped, hollow
frame implant with lateral fenestrations. The spacers incorporate
three (3) Tantalum marker pins to aid in radiographic
visualization.
The Stryker Spine AVS® TL PEEK Spacer is available in a
variety of sizes, from 7 mm to 18mm in height, two (2) lengths:
25 mm and 30 mm and one (1) width: 9 mm. There are also 0°
parallel and 4° wedge shaped options, which allows the surgeon
to best choose the size suited to the patient's anatomy and
pathology. |
| Intended Use | The Stryker Spine AVS® TL 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 $1.
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 spinal fixation systems that have been cleared for
use in the lumbosacral spine (i.e., posterior pedicle screw and
rod systems). |
| Summary of the
Technological
Characteristics | Testing in compliance with FDA's June 12, 2007 "Class II
Special Controls Guidance Document: Intervertebral Body
Fusion Device" was performed for the AVS® TL PEEK Spacers
and demonstrated substantial equivalent performance
characteristics to the identified predicate device systems. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with outstretched wings and three legs.
Public Health Service
FEB 2-7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Corporation % Stryker Spine Ms. Kimberly Lane 2 Pearl Court Allendale, New Jersey 07401
Re: K083661
Trade/Device Name: Stryker Spine AVS® TL PEEK Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: December 9, 2008 Received: December 10, 2008
Dear Ms. Lane:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 (21 CFR Part 807); labeling (21 CFR Part 801); 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,
3
Page 2 – Ms. Kimberly Lane
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
R.A. m.d. fo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Stryker Spine AVS® TL PEEK Spacers
Traditional 510(k) Premarket Notification
Indications for Use
510(k) Number (if known): KOS 3461 Device Name: Stryker Spine AVS® TL PEEK Spacers
Indications For Use:
The Stryker Spine AVS® TL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft bone 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 Spacers are to be implanted via posterior approach.
The AVS® TL 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 (Part 21 CFR 801 Subpart D) 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)
AND/OR
Page 1 of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Numbe