# K210192: A.L.P.S. Clavicle Plating System

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Feb 19, 2021 after 25 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.
2 later devices descend from it; 1 cites it directly.
0 of 5 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 4.

## Most influential descendants
- K250494: The OsteoCentric Bone Plate and Screw System (2025), 1 descendant of its own
- K251913: OsteoCentric® UnifiMI® TCS Plating System (2025), 0 descendants of its own

## Indications for use
The A.L.P.S. Clavicle Plating System is indicated for fixation of fractures, osteotomies and nonunions of the clavicle including osteopenic bone.

Source page: https://510kreport.com/device/K210192
Methodology: https://510kreport.com/methodology