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AperFix Femoral Implant with Inserter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K062487

by Cayenne Medical, Inc.

Identifiers

510(k) Number
K062487 FDA 510(k)
FDA Product Code
HWC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The AperFix Femoral Implant with Inserter is a non-absorbable internal fixation device classified as a ligament fixation device. It is designed to secure soft tissue grafts to bone during ligament reconstruction procedures, such as ACL, PCL, MCL, or LCL repairs, using either arthroscopic or open surgical techniques. The system includes a body, wedge, and two deployable arms with compression pads to ensure stable tendon-to-bone fixation.

This device is supplied in diameters of 9 mm, 10 mm, and 11 mm and is intended for single-use. It is regulated under the FDA’s 510(k) clearance process, classified under the Orthopedic advisory committee with a product code of HWC. The device is not explicitly stated as sterile or reusable in the provided data, but its single-use nature is implied by its design and regulatory submission context.

Frequently asked questions

What surgical procedures is the AperFix Femoral Implant with Inserter intended to support during ligament reconstruction?

The AperFix Femoral Implant with Inserter is specifically designed to secure soft tissue grafts to bone during ligament reconstruction procedures, including ACL (anterior cruciate ligament), PCL (posterior cruciate ligament), MCL (medial collateral ligament), and LCL (lateral collateral ligament) repairs. It is compatible with both arthroscopic and open surgical techniques.

How is the AperFix Femoral Implant with Inserter supplied, and what sizes are available?

The AperFix Femoral Implant with Inserter is supplied in three diameters: 9 mm, 10 mm, and 11 mm. It is intended for single-use, as implied by its design and regulatory submission context, and is part of a system that includes a body, wedge, and deployable arms with compression pads.

Is the AperFix Femoral Implant with Inserter sterile, and how should it be stored?

The provided data does not explicitly state whether the AperFix Femoral Implant with Inserter is sterile, but its single-use nature suggests it should be handled as a sterile device. For proper storage, follow manufacturer guidelines, typically involving a clean, dry environment away from direct sunlight and extreme temperatures until ready for use.

What regulatory pathway was used for the FDA clearance of the AperFix Femoral Implant with Inserter, and what product code does it fall under?

The AperFix Femoral Implant with Inserter received FDA clearance through the 510(k) process, specifically under the Traditional clearance type. It is classified under the Orthopedic advisory committee and falls under the product code HWC, as recorded in the FDA submission.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF The AperFix® System AM Portal Surgical Technique, PDF 510(k) Summary NOV 17 Z006 Cayenne Medical, Inc. AperFix Femoral ..., PDF The AperFix® II System Transtibial Surgical Technique

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cayenne Medical, Inc.

Sources (1)

  • FDA 510(k) K062487 24 fields · synced Sep 19, 2026