← Back to catalogue

Aperfix Implant With Inserter, 8, 9, 10, 11, MM X30 MM

FDA 510(k)

Class II (US FDA 510(k))

510(k) K083607

by Cayenne Medical, Inc.

Identifiers

510(k) Number
K083607 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 Implant is a non-absorbable internal fixation device for tendon-to-bone attachment. The system comprises a screw and a two-part screw sheath, available in 8, 9, 10, and 11 mm diameters with 30 mm length. It is designed for ligament reconstruction procedures by orthopedic surgeons in clinical or operating room settings.

The device is supplied sterile with a single-use inserter. It is intended for use in soft tissue multi-ligament reconstruction of the knee. The device has received FDA 510(k) clearance with the product code HWC and is classified under the orthopedic advisory committee.

Frequently asked questions

What is the Aperfix Implant used for?

The Aperfix Implant is a non-absorbable internal fixation device designed for tendon-to-bone attachment, specifically intended for soft tissue multi-ligament reconstruction of the knee by orthopedic surgeons in clinical or operating room settings.

What sizes are available for the Aperfix Implant?

The Aperfix Implant system is available in four different diameters: 8mm, 9mm, 10mm, and 11mm, all with a 30mm length. Each implant comes with a single-use inserter for application.

How is the Aperfix Implant supplied?

The device is supplied sterile with a single-use inserter. It is designed for one-time use only and should not be reused or resterilized to ensure patient safety and device integrity.

What is the regulatory status of the Aperfix Implant?

The Aperfix Implant has received FDA 510(k) clearance with the product code HWC and is classified under the orthopedic advisory committee. It was determined to be substantially equivalent to predicate devices.

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: Aperfix Implant With Inserter, 8, 9, 10, 11, Mm X30 Mm, PDF The AperFix® System AM Portal Surgical Technique, PDF 510(k) Summary DEC 1 4 Z006 Cayenne Medical, Inc. AperFixTM Tibial ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cayenne Medical, Inc.

Sources (1)

  • FDA 510(k) K083607 24 fields · synced Oct 6, 2026