# K222244: Arthrex 3.5 mm Locking Compression Plates

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Sep 30, 2022 after 66 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: 10 generations back to K000684 (2000). 75 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123241: Arthrex Fracture Plates, Arthrex, Inc. (2013) Summary page 4.

## Most influential descendants
- K253713: Arthrex Variable Angle (VA) Proximal Tibia Plating System (2026), 0 descendants of its own

## Indications for use
The Arthrex 3.5 mm Locking Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula.

Source page: https://510kreport.com/device/K222244
Methodology: https://510kreport.com/methodology