# K173767: A. L. P. S. Clavicle Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 6, 2018 after 116 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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: 1 generation back to K083843 (2009). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 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.

## Most influential descendants
- K210192: A.L.P.S. Clavicle Plating System (2021), 2 descendants of its own
- K250494: The OsteoCentric Bone Plate and Screw System (2025), 1 descendant of its own
- K254288: Clavicle Fixation System (2026), 0 descendants of its own
- K251913: OsteoCentric® UnifiMI® TCS Plating System (2025), 0 descendants of its own

## Recalls of this device
- Dec 23, 2020 · Class II · Z-0882-2021: The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance o
- May 14, 2020 · Class II · Z-2308-2020: Distributed to the field without having completed design history files or design transfer activities

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

Source page: https://510kreport.com/device/K173767
Methodology: https://510kreport.com/methodology