# K243995: Arthrex Humeral Plating System and Cerclage Button

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Mar 26, 2025 after 90 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: 13 generations back to K962616 (1996). 131 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180310: DePuy Synthes Trauma Orthopedic Plates and Screws, Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. (2018) Summary page 5.
- K172975: DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional, Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. (2018) Summary page 5.

## Most influential descendants
- K260353: Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (2026), 0 descendants of its own

## 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/K243995
Methodology: https://510kreport.com/methodology