# K254288: Clavicle Fixation System

- Pathway: 510(k) (Abbreviated)
- Applicant: Skeletal Dynamics, Inc.
- Decided: Mar 23, 2026 after 82 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K083843 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173767: A. L. P. S. Clavicle Plating System, Biomet, Inc. (2018) Summary page 5.

## Indications for use
The Skeletal Dynamics Clavicle Fixation System is indicated for fractures, osteotomies, and non-unions of the Clavicle including osteopenic bone.

Source page: https://510kreport.com/device/K254288
Methodology: https://510kreport.com/methodology