AFX Femoral Implant With Inserter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161033 FDA 510(k)
- FDA Product Code
- MBI 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 AFX Femoral Implant With Inserter is a non-absorbable internal fixation device classified as a bone anchor (product code MBI) under FDA nomenclature. It is designed to secure tendon grafts, such as hamstring tendons, to bone during anterior cruciate ligament (ACL) reconstruction procedures. The device features a body, wedge, and two deployable arms with compression pads to ensure stable fixation. Its primary function is to provide reliable tendon-to-bone attachment in both arthroscopic and open surgical techniques.
This device is supplied sterile and intended for single-use. It is available in diameters of 9 mm, 10 mm, and 11 mm, with an included inserter for precise placement. The AFX Femoral Implant With Inserter is regulated under the FDA’s 510(k) clearance (K161033) as a Special submission, classified under the Orthopedic (OR) advisory committee. Storage and handling must comply with sterile medical device protocols to maintain integrity before use.
Frequently asked questions
What surgical techniques can the AFX Femoral Implant With Inserter be used for during ACL reconstruction?
The AFX Femoral Implant With Inserter is designed for use in both arthroscopic and open surgical techniques to secure tendon grafts, such as hamstring tendons, to the femur during anterior cruciate ligament (ACL) reconstruction. Its deployable arms and compression pads ensure stable fixation regardless of the approach.
Is the AFX Femoral Implant With Inserter intended for reuse, or is it meant to be used only once?
The AFX Femoral Implant With Inserter is explicitly intended for single-use only. This is standard practice for sterile medical devices to ensure patient safety and prevent cross-contamination.
What sizes are available for the AFX Femoral Implant With Inserter, and how does this affect its use?
The AFX Femoral Implant With Inserter is available in three diameters: 9 mm, 10 mm, and 11 mm. These sizes accommodate different patient anatomies and graft sizes, allowing surgeons to select the appropriate implant for optimal tendon-to-bone fixation during ACL reconstruction.
How is the AFX Femoral Implant With Inserter supplied, and what does this mean for its handling?
The AFX Femoral Implant With Inserter is supplied sterile and includes an inserter tool for precise placement. This means it must be stored and handled according to sterile medical device protocols to maintain its integrity before use, ensuring a clean surgical field and reducing infection risks.
What regulatory pathway was followed for the AFX Femoral Implant With Inserter, and how does this impact its use?
The AFX Femoral Implant With Inserter was cleared through the FDA’s 510(k) pathway as a Special submission under the Orthopedic (OR) advisory committee. This classification confirms it is deemed substantially equivalent to a predicate device, ensuring it meets FDA standards for safety and effectiveness as a bone anchor (product code MBI) for ACL reconstruction.
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: AFX Femoral Implant with Inserter (K192428) — FDA 510(k) | Innolitics, PDF 510(k) Summary NOV 17 Z006 Cayenne Medical, Inc. AperFix Femoral ..., PDF Cayenne Medical Shima Hashemian QA/RA Associate Director 16597 N 92nd ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161033 | Class II | Active |
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Manufacturer
- Manufacturer
- Cayenne Medical, Inc.
Sources (1)
- FDA 510(k) K161033 24 fields · synced Sep 20, 2026