CAYMAN BUTTRESS PLATE SYSTEM

K080302 · K2m, Inc. · KWQ · Mar 24, 2008 · Orthopedic

Device Facts

• Record ID: K080302
• Device Name: CAYMAN BUTTRESS PLATE SYSTEM
• Applicant: K2m, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

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 or autografts. The device is not intended for load bearing indications.

Device Story

Cayman Buttress Plate System consists of plates and screws for anterior lumbar spine fixation; non-load bearing; used in spinal fusion procedures to stabilize and buttress tissue in intervertebral space; maintains relative position of weak bony tissue (allografts/autografts); operated by surgeons in clinical/OR settings.

Technological Characteristics

Materials: CP Titanium and Ti6Al4V per ASTM and ISO standards. Form factor: Plates and screws of various sizes. Non-load bearing. Mechanical fixation.

Indications for Use

Indicated for use in spinal fusion procedures to maintain the relative position of weak bony tissue (e.g., allografts or autografts). Not for load-bearing indications.

Regulatory Classification

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.

Predicate Devices

• Seaspine Anterior Lumbar Buttress System
• BowTi Anterior Staple System
• Synthes Titanium Locking Plate System
• Altiva Buttress Plating System
• Medtronic Sofamor Danek Bone Graft Washer

Submission Summary (Full Text)

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K080302

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.

1. 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: [phone]

2. 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

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded helix intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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