# K122463: Aperfix AM Femoral Implant with Inserter, 9X24 Aperfix AM Femoral Implant with Inserter, 10X24 Aperfix Femoral Implant W

- Pathway: 510(k) (Special)
- Applicant: Cayenne Medical, Inc.
- Decided: Oct 11, 2012 after 59 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: 1 generation back to K083612 (2009). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083612: Aperfix Femoral Implant with Inserter, 9,10,11 MM X 35MM and X 29MM, Cayenne Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K161033: AFX™ Femoral Implant With Inserter (2016), 1 descendant of its own
- K192428: AFX Femoral Implant with Inserter (2019), 0 descendants of its own

## Indications for use
The AperFix AM Femoral Implant 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 (MLPFL) reconstruction.

Source page: https://510kreport.com/device/K122463
Methodology: https://510kreport.com/methodology