(84 days)
The Stryker Spine AVS® ALign 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® ALign PEEK Spacers are to be implanted via anterior or anterolateral approach. The AVS® ALign PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
This Special 510(k) premarket notification is intended to introduce the new sizes to the AVS® AL PEEK Spacer family cleared under K090166. Note that the AVS® ALign PEEK Spacers may also be referred to as AVS® AL spacers. The Stryker Spine AVS® ALign 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® ALign PEEK Spacers are to be implanted via anterior or anterolateral approach. The AVS® ALign PEEK Spacers are intended to be used with supplemental fixation plate and rod systems that have been cleared for use in the lumbosacral spine. Testing in compliance with FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the AVS® ALign PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems.
The provided text describes a Special 510(k) premarket notification for modifications to an intervertebral body fusion device, the AVS® ALign PEEK Spacer System. This filing is primarily to introduce new sizes to an existing device family cleared under K090166.
The document does not contain information regarding acceptance criteria or a study proving that the device meets such criteria. It explicitly states that "Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed for the AVS® ALign PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems." This indicates that the device's performance was evaluated against a guidance document and found to be substantially equivalent to predicates, but it does not detail specific acceptance criteria or the results of the specific performance tests.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets these criteria. The document focuses on regulatory approval based on substantial equivalence, rather than detailed performance study results against specific, quantifiable acceptance criteria.
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MAR 1 1 2010
Special 510(k) Summary of Safety and Effectiveness: Modifications to the AVS® AL PEEK Spacer System
AVS® ALign PEEK Spacer System Proprietary Name: Spinal Fixation Appliances Common Name: Proposed Regulatory Class: Class II Intervertebral body fusion device 21 CFR 888.3080 MAX Device Product Code:
For Information contact:
Date Summary Prepared: Predicate Device
Predicate Device Information
Kimberly Lane Regulatory Affairs Specialist 2 Pearl Court Allendale, NJ 07401 Telephone: (201) 760-8215 Fax: (201) 760-8415 Email: kimberly.lane@stryker.com
December 16, 2009 AVS® AL PEEK Spacers (K090166) and DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP Spine System: P960025 (i.e., Brantigan Cage) The subject AVS® ALign PEEK Spacers and the predicate AVS® AL 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
Materials and mechanical testing results are similar between the subject device and the listed predicates.
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This Special 510(k) premarket notification is intended to Description of Device Modification introduce the new sizes to the AVS® AL PEEK Spacer family cleared under K090166. Note that the AVS® ALign PEEK Spacers may also be referred to as AVS® AL spacers. The Stryker Spine AVS® ALign PEEK Spacers are intervertebral body fusion devices indicated for use with Intended Use 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® ALign PEEK Spacers are to be implanted via anterior or anterolateral approach. The AVS® ALign PEEK Spacers are intended to be used with supplemental fixation plate and rod systems that have been cleared for use in the lumbosacral spine. Testing in compliance with FDA's June 12, 2007 "Class II Summary of the Technological Special Controls Guidance Document: Intervertebral Body Characteristics Fusion Device" was performed for the AVS® ALign PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
MAR 1 1 2010
Stryker Corporation % Ms. Kimberly S. Lane Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K093864
Trade/Device Name: AVS® Align PEEK Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: February 18, 2010 Received: February 19, 2010
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. 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 (21
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Page 2 - Ms. Kimberly S. Lane
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,
Pavlova Buchin
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K
Device Name: Stryker Spine AVS® ALign PEEK Spacers
Indications For Use:
The Stryker Spine AVS® ALign 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® ALign PEEK Spacers are to be implanted via anterior or anterolateral approach.
The AVS® ALign PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
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)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093864
§ 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.