# K041261: Femoral Hook

- Pathway: 510(k) (Special)
- Applicant: Arthrotek, Inc.
- Decided: Jun 7, 2004 after 27 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922559 (1992). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033838: Titanium Toggle Button (S), Biomet Manufacturing, Inc. (2004) Summary page 1.

## Most influential descendants
- K053461: Ezloc Femoral Fixation Device (2006), 0 descendants of its own

## Recalls of this device
- Apr 17, 2008 · Not classified · Z-1782-2008: This recall was initiated following an investigation which identified that: EZLoc Femoral Fixation devices, from two finished good lots were distributed with the incorrect component size inside the pa
- Apr 17, 2008 · Not classified · Z-1783-2008: This recall was initiated following an investigation which identified that: EZLoc Femoral Fixation devices, from two finished good lots were distributed with the incorrect component size inside the pa

## Indications for use
Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

Source page: https://510kreport.com/device/K041261
Methodology: https://510kreport.com/methodology