# K083612: Aperfix Femoral Implant with Inserter, 9,10,11 MM X 35MM and X 29MM

- Pathway: 510(k) (Traditional)
- Applicant: Cayenne Medical, Inc.
- Decided: Mar 4, 2009 after 89 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K122463: Aperfix AM Femoral Implant with Inserter, 9X24 Aperfix AM Femoral Implant with Inserter, 10X24 Aperfix Femoral Implant W (2012), 2 descendants of its own
- K161033: AFX™ Femoral Implant With Inserter (2016), 1 descendant of its own
- K192428: AFX Femoral Implant with Inserter (2019), 0 descendants of its own

## Recalls of this device
- Jul 11, 2013 · Class II · Z-2422-2018: Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.

## Indications for use
The AperFix 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/K083612
Methodology: https://510kreport.com/methodology