# K053461: Ezloc Femoral Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Arthrotek, Inc.
- Decided: Feb 3, 2006 after 52 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: 5 generations back to K922559 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
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.
- K041261: Femoral Hook, Arthrotek, Inc. (2004) Summary page 1.

## 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/K053461
Methodology: https://510kreport.com/methodology