# K230945: Forma Medical Headless Compression Screw

- Pathway: 510(k) (Traditional)
- Applicant: Forma Medical, Inc.
- Decided: Jul 18, 2023 after 105 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: 1 generation back to K090949 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090949: Synthes (Usa) 1.5MM Headless Compression Screws, Synthes (Usa) (2009) Summary page 4.

## Indications for use
Forma Medical Headless Compression Screws are indicated for fixation of intra-articular and extra articular fractures, avulsions, non-unions, and osteotomies of small bones and small bone fragments; as well as arthrodesis of small joints.

Source page: https://510kreport.com/device/K230945
Methodology: https://510kreport.com/methodology