# K192428: AFX Femoral Implant with Inserter

- Pathway: 510(k) (Special)
- Applicant: Cayenne Medical
- Decided: Oct 5, 2019 after 30 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K083612 (2009). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161033: AFX™ Femoral Implant With Inserter, Cayenne Medical, Inc. (2016)

## Indications for use
The AFX Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts, utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.

Source page: https://510kreport.com/device/K192428
Methodology: https://510kreport.com/methodology