# K172383: Arthrosurface Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Arthrosurface, Inc.
- Decided: Dec 22, 2017 after 136 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: 12 generations back to K962616 (1996). 156 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 158 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143614: Arthrex Low Profile Screws, Arthrex, Inc. (2015) Summary page 5.
- K112437: Arthrex Fracture System, Arthrex, Inc. (2011) Summary page 5.
- K103705: Low Profile Screws, Arthrex, Inc. (2011) Summary page 5.
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 5.
- K161539: Arthrosurface Bone Screws, Arthrosurface, Inc. (2016) Summary page 5.

## Most influential descendants
- K200226: RetroFix (2020), 0 descendants of its own

## Indications for use
The Arthrosurface Bone Screws (2.0-3.0 mm solid and cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist. The Arthrosurface Bone Screws (3.5 mm and larger, solid and cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, shoulder, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula.

Source page: https://510kreport.com/device/K172383
Methodology: https://510kreport.com/methodology