# K143697: Biomet Proximal Humerus Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing
- Decided: Mar 30, 2015 after 96 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K042059 (2004). 10 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955472: Ace Humerus & Radius Plates, Ace Medical Co. (1996) Summary page 4.
- K060290: Shoulder Fixation System, Hand Innovations, LLC (2006) Summary page 4.
- K101421: Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model 131218704-708; 851318704-708, 131218204, DePuy Orthopaedics, Inc. (2010) Summary page 4.

## Most influential descendants
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own
- K202496: ANTHEM Fracture System (2020), 8 descendants of its own
- K212433: Anthem Fracture System (2021), 7 descendants of its own

## Recalls of this device
- May 14, 2020 · Class II · Z-2315-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2316-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2309-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2318-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2312-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2314-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2306-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2317-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2324-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2307-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2319-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2323-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2305-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2313-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2320-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2321-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2322-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2311-2020: Distributed to the field without having completed design history files or design transfer activities

## Indications for use
The Biomet 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/K143697
Methodology: https://510kreport.com/methodology