# K222799: Haymaker® Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Orthocircle Spine D.B.A. OC Medical Devices
- Decided: Jan 10, 2023 after 116 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). 180 ancestors in all.
No later device cites it as a predicate yet.
0 of 181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183603: INnate Cannulated Screw System, Exsomed Corporation (2019) Summary page 4.
- K171558: ExsoMed ITN Cannulated Screw System, Exsomed Holdings Company, LLC (2017) Summary page 4.
- K172617: Treace Medical Concepts (TMC) Compression Screw System, Treace Medical Concepts, Inc. (2017) Summary page 4.

## Indications for use
The Haymaker® Screw System is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

Source page: https://510kreport.com/device/K222799
Methodology: https://510kreport.com/methodology