# K242079: Arthrex Elbow Fracture Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Nov 14, 2024 after 121 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: 8 generations back to K962616 (1996). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061352: Peri-Loc Periarticular Locked Plating System for the Upper Extremity, Smith & Nephew, Inc. (2006) Summary page 5.

## Indications for use
The distal humerus fracture plates and olecranon fracture plates are indicated for adult patients. The distal humerus and olecranon fracture plates are indicated for fixation of fractures of the humerus and ulna.

Source page: https://510kreport.com/device/K242079
Methodology: https://510kreport.com/methodology