# K162424: Ulna Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 12, 2016 after 43 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: 1 generation 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)
- K083843: Locking Anatomic & Composite Plating System, DePuy Orthopaedics, Inc. (2009) Summary page 4.
- K112345: Distal Volar Radius Plating Systems, Medos International SARL (2011) Summary page 4.

## Indications for use
The System is indicated for fixation of fractures, osteotomies and non-unions of the ulna, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K162424
Methodology: https://510kreport.com/methodology