# K251620: A.L.P.S. Proximal Humerus Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Biomet
- Decided: Jul 25, 2025 after 59 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: 4 generations back to K042059 (2004). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143697: Biomet Proximal Humerus Plating System, Biomet Manufacturing (2015) Summary page 5.

## Indications for use
The A.L.P.S Proximal Humerus Plating System is indicated for fixation of fractures and fracture dislocations, fusions, osteotomies and non-unions of the humerus, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K251620
Methodology: https://510kreport.com/methodology