The AperFix™ Tibial 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 AperFix Tibial Implant is a device that provides soft tissue compression within the prepared tibial tunnel to anchor the tendon. It includes a screw and a two-part screw sheath. AperFix Tibial Implants are available in diameters of 9, 10 and 11 mm with a standard length of 30 mm. Each AperFix Tibial Implant is supplied with the implant screw pre-loaded on a disposable inserter. The role of the inserter is to assist in implant placement within the tibial tunnel.

The AperFix Tibial Implant screw and sheath are manufactured from PEEK-OPTIMA** LT (polyetheretherketone), a biocompatible polymer manufactured by Invibio Inc.

AI/ML Overview

The provided text is a 510(k) summary for the AperFix™ Tibial Implant with Inserter, a medical device for bone fixation. However, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, nor does it refer to an AI/ML device.

Therefore, I cannot provide the requested information in the specified format because the input utterly lacks the descriptions of acceptance criteria, device performance, sample sizes, provenance, expert qualifications, ground truth establishment, or any details related to a clinical study or AI/ML algorithm evaluation.

The document is purely administrative, detailing the device's classification, intended use, and a declaration of substantial equivalence to predicate devices, which is a regulatory pathway for approval, not a performance study.

Summary

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510(k) Summary

AperFix™ Tibial Implant with Inserter

K063.70 P.g. 192

510(k) Summary

DEC 1 4 2006

Cayenne Medical, Inc. AperFix™ Tibial Implant with Inserter

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Cayenne Medical, Inc.8541 E Anderson Drive, Suite 100Scottsdale, AZ 85255Telephone (480) 520-3661Fax (480) 520-3670
Official Contact:	Derek Harper
Representative/Consultant:	Floyd G. LarsonPaxMed International, LLC11234 El Camino Real, Suite 200San Diego, CA 92130Telephone (858) 792-1235Fax (858) 792-1236
DEVICE NAME
Classification Names:	Screw, fixation, bone
Trade/Proprietary Name:	AperFix™ Tibial 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.

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INTENDED USE

The AperFix™ Tibial 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 AperFix Tibial Implant screw and sheath are manufactured from PEEK-OPTIMA** LT (polyetheretherketone), a biocompatible polymer manufactured by Invibio Inc.

EQUIVALENCE TO MARKETED PRODUCT

Cayenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the AperFix Tibial 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2006

PaxMed International, LLC % Mr. Floyd G. Larson 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K063070

Trade/Device Name: AperFix™ Tibial 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: October 5 2006 Received: October 6, 2006

Dear Mr. Larson:

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. 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,

Saubara Buchup

Mark N. Melkers 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

063.70 510(k) Number (if known):

Device Name: AperFix™ Tibial Implant with Inserter

Indications for Use:

The AperFix™ Tibial 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 NO AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)
Division of General, Restorative, and Neurological Devices	Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number	K063070

Regulation Number and Section

N/A