# K041965: Arthrex Humeral Fracture Plates and Screws

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Sep 8, 2004 after 49 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: 1 generation back to K983853 (1998). 5 ancestors in all.
35 later devices descend from it; 6 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011334: Synthes Curved Reconstruction Plate, Synthes (Usa) (2001) Summary page 1.
- K031178: Synthes (Usa) 3.5 MM Broad LCP & 4.5 MM LCP Distal Humerus Plates, Synthes (Usa) (2003) Summary page 1.
- K032559: Synthes 4.0MM Titanium (TI.) Locking Screws, Synthes (Usa) (2003) Summary page 1.
- K011170: Synthes 2.7 MM LC-DCP, 3.5 MM Profile, Synthes (Usa) (2001) Summary page 1.
- K983853: Depuy Ace Timax Meta Plate, Depuy Ace Medical Co. (1998) Summary page 1.

## 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

## Indications for use
The Arthrex Humeral Fracture Plates and Screws are intended to provide internal fixation of proximal fractures of the humerus.

Source page: https://510kreport.com/device/K041965
Methodology: https://510kreport.com/methodology