Properly used in conjunction with traditional rigid fixation, this 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. This device is not intended for load bearing indications.

Device Description

The GAPP™ Graft Containment Device consists of bone fixation devices used in spinal fusion procedures. The graft containment device is available in a wide range of sizes for use in maintaining the relative position of weak bony tissue such as bone grafts. The graft containment device implants maintain the stability of weak bony tissue during the healing period.

AI/ML Overview

The provided text is a 510(k) summary for the GAPP™ Graft Containment Device. It states that "Documentation was provided which demonstrated the GAPP™ Graft Containment Device to be substantially equivalent to the MacroPore OS Implant."

This type of submission is a claim of substantial equivalence, which means the device is being compared to a "predicate device" that has already been cleared by the FDA. The 510(k) summary provided does not contain independent acceptance criteria for the GAPP™ device or a study proving that the GAPP™ device meets specific performance criteria through direct testing.

Therefore, I cannot provide the requested information because the document describes a substantial equivalence claim rather than a detailed performance study with explicit acceptance criteria. The information requested (such as sample size, ground truth, expert qualifications, etc.) would typically be found in a detailed clinical or performance study report, which is not present in this 510(k) summary.

Summary

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K031782

GAPP™ Graft Containment Device 510(k) Summary June 2003

page 1 of 1

Medtronic Sofamor Danek Company: I. 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

Proprietary Trade Name: GAPP™ Graft Containment Device II.

Regulation Number: 888.3060 - KWQ III.

IV. Product Description

Indications V.

Substantial Equivalence VI.

Documentation was provided which demonstrated the GAPP™ Graft

Containment Device to be substantially equivalent to the MacroPore OS Implant.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

FEB - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Richard Treharne, Ph.D. Senior Vice President Regulatory Affairs Medtronic Sofamor Danek, Inc. 1800 Pyramid Place Memphis. Tennessee 38132

Re: K031782

Trade/Device Name: GAPP™ Graft Containment Device Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 1, 2004 Received: December 2, 2004

Dear Dr. Treharne:

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 - Richard W. Treharne, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and h your e FDA finding of substantial equivalence of your device to a legally promance motificated. " 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,
Mark A. Millhiser

Celia M. Witten,Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):__ K031782

Device Name: GAPP™ Graft Containment Device

Indications for Use:

X Prescription Use (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)

for Mark N Millman

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K031782

Regulation Number and Section

N/A