# K190921: Arthrex Low Profile Screws

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Oct 30, 2019 after 204 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K000684 (2000). 76 ancestors in all.
No later device cites it as a predicate yet.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141735: Arthrex Ankle Fusion Plating System, Arthrex, Inc. (2014) Summary page 4.

## Indications for use
The Arthrex Low Profile Screws are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot and ankle. The screws may be used with the Arthrex Ankle Fusion Plates.

Source page: https://510kreport.com/device/K190921
Methodology: https://510kreport.com/methodology