APERFIX FEMORAL IMPLANT WITH INSERTER

{0}------------------------------------------------ 510(k) Summary AperFix™ Femoral Implant with Inserter # 510(k) Summary NOV 17 2006 # Cayenne Medical, Inc. AperFix Femoral Implant with Inserter ## ADMINISTRATIVE INFORMATION | Manufacturer Name: | Cayenne Medical, Inc.<br>8541 E Anderson Drive, Suite 100<br>Scottsdale, AZ 85255<br>Telephone (480) 520-3661<br>FAX (480) 520-3670 | |----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | Official Contact: | Derek Harper | | Representative/Consultant: | Floyd G. Larson<br>PaxMed International, LLC<br>11234 El Camino Real, Suite 200<br>San Diego, CA 92130<br>Telephone (858) 792-1235<br>FAX (858) 792-1236 | | DEVICE NAME | | | Classification Names: | Screw, fixation, bone | | Trade/Proprietary Name: | AperFix™ Femoral Implant with Inserter | | Common Name: | Bone screw | ### DEVICE CLASSIFICATION FDA has classified bone screws as Class II devices (21 CFR 888.3040). The product code for screw, fixation, bone is HWC. These devices are reviewed by the Orthopedic Joint Devices Branch {1}------------------------------------------------ #### INTENDED USE The AperFix™ Femoral Implant with Inserter is intended for use with soft tissue grafts to provide tendon to bone fixation during arthroscopic or open ACL reconstruction procedures. #### DEVICE DESCRIPTION The Cayenne Medical AperFix™ Femoral Implant with Inserter is a non-absorbable internal fixation device intended to provide tendon to bone fixation in hamstring tendon arthroscopic or open anterior cruciate ligament (ACL) reconstruction. It includes a body, wedge and two deployable arms with compression pads. AperFix Femoral Implants are available in diameters of 9, 10 and 11 mm with a standard length of 35 mm. Each device is intended for single use and is pre-loaded on a sterile inserter. The AperFix Femoral Implant with Inserter will be supplied sterile. Sterilization will be accomplished by means of Co60 gamma irradiation at a dose of 25-40 kGy . Mechanical testing was performed on the AperFix Femoral Implant. It was shown that pull-out strength is significantly higher than that of a predicate interference screw. #### EQUIVALENCE TO MARKETED PRODUCT Cayenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the AperFix Femoral Implant with Inserter is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices. {2}------------------------------------------------ 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 stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text arranged in a circular pattern, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 PaxMed International, LLC % Mr. Floyd G. Larson 11234 El Camino Real, Suite 200 San Diego, California 92130 NOV 17 2006 Re: K062487 Trade/Device Name: AperFix"M Femoral Implant with Inserter Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 24, 2006 Received: August 25, 2006 Dear Mr. Larson: We have reviewed your Scction 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 – Mr. Floyd G. Larson 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Indications for Use 510(k) Number (if known): _ Kob2487 Device Name: AperFix™ Femoral Implant with Inserter Indications for Use: The AperFix™ Femoral Implant with Inserter is intended for use with soft tissue grafts to provide tendon to bone fixation during arthroscopic or open ACL reconstruction procedures. Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division igh «Off Division of General, Restorative, and Neurological Devices **510(k) Number** *L062487*