(48 days)
The Cayman Buttress Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
The Cayman Buttress Plate System are non-load bearing devices, each consisting of a screw and plate of various sizes and screw for attachment to the vertebral body in the anterior lumbar spine. Materials: The devices are manufactured from CP Titanium and Ti6Al4V per ASTM and ISO standards. Function: The plates are designed to be used in spinal fusion procedures to provide stabilization and buttressing of tissue in the intervertebral space.
The provided text is a 510(k) summary for the Cayman Buttress Plate System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full study to meet specific performance acceptance criteria. Therefore, the document does not contain the information requested regarding specific acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC comparative effectiveness studies.
The summary states: "The Cayman Buttress Plate System is considered substantially equivalent to other legally marketed devices. They are similar in design, material, and indications for use and are expected to be equivalent in safety and effectiveness."
This means the "acceptance criteria" for this submission are based on demonstrating similarity to already approved devices, rather than meeting quantitative performance metrics through a clinical or rigorous standalone study.
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Summary of Safety and Effectiveness for the Cayman Buttress Plate System
MAR 2 4 2008
This safety and effectiveness summary for the System is provided as required per Section 513(i(i(3) of the Food, Drug and Cosmetic Act.
- Submitter :
K2M, Inc. 751 Miller Drive SE, Suite F1 Leesburg, VA 20175
Date Prepared:
Contact Person : Richard W. Woods K2M, LLC 751 Miller Drive SE, Suite Fl Leesburg, VA 20175 Telephone: 703-777-3155
- Tradename: Cayman Buttress Plate System Common Name: Buttress Plate Classification Name: Spinal intervertebral body fixation orthosis (21 CFR 888.3060)
3. Predicate or legally marketed devices which are substantially equivalent :
- . Seaspine Anterior Lumbar Buttress System
- . BowTi Anterior Staple System
- Synthes Titanium Locking Plate System .
- . Altiva Buttress Plating System
- . Medtronic Sofamor Danek Bone Graft Washer
4. Description of the device:
The Cayman Buttress Plate System are non-load bearing devices, each consisting of a screw and plate of various sizes and screw for attachment to the vertebral body in the anterior lumbar spine.
Materials: The devices are manufactured from CP Titanium and Ti6Al4V per ASTM and ISO standards,
Function: The plates are designed to be used in spinal fusion procedures to provide stabilization and buttressing of tissue in the intervertebral space.
5. Intended Use:
The Cayman Buttress Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing indications.
6. Comparison of the technological characteristics of the device to predicate and legally marketed devices :
The Cayman Buttress Plate System is considered substantially equivalent to other legally marketed devices. They are similar in design, material, and indications for use and are expected to be equivalent in safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2008
K2M, Inc. % Mr. Richard W. Woods 751 Miller Drive SE, Suite F-1 Leesburg, VA 20175
Re: K080302
Trade/Device Name: Cayman Buttress Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: Feb 04, 2008 Received: Feb 07, 2008
Dear Mr. Woods:
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.
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Page 2 - Mr. Richard W. Woods
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,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Cayman Buttress Plate System
Indications for Use:
The Cayman Buttress Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS-LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jouta
Division of General, Restorative, and Neurological Devices
510(k) Number. K080302
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.