# K260353: Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Mar 3, 2026 after 28 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: 14 generations back to K962616 (1996). 132 ancestors in all.
No later device cites it as a predicate yet.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243995: Arthrex Humeral Plating System and Cerclage Button, Arthrex, Inc. (2025) Summary page 5.
- K180310: DePuy Synthes Trauma Orthopedic Plates and Screws, Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. (2018) Summary page 5.

## Indications for use
The Humeral Plating System is indicated for fractures and fracture-dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone. The Cerclage Button is intended for use with the humeral plating system and FiberTape® cerclage suture, to augment fracture stabilization with humeral plates in long bone fixation. The cerclage button is designed for use with the humeral plating system and may not be used alone.

Source page: https://510kreport.com/device/K260353
Methodology: https://510kreport.com/methodology