# K200259: Headless Compression Screw System

- Pathway: 510(k) (Special)
- Applicant: Osteocentric Extremities, LLC
- Decided: May 4, 2020 after 91 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: 2 generations back to K792022 (1979). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170021: SMV Scientific Cannulated Screws, Smv Scientific (2017) Summary page 4.
- K081011: Arex Scru 2 Headless Compression Screws, Models: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45, Arex USA (2008) Summary page 5.

## Indications for use
The Headless Compression Screw System Micro-2.8 screw fasteners are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies. The Headless Compression Screw System Mini-3.9 screw fasteners are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodeses of the carpals and phalanges, steochondritis dissecans, and ligament fixation. The screw fasteners are intended for single use only and may not be reused under any circumstances. The system drills and guide wires are single use instruments.

Source page: https://510kreport.com/device/K200259
Methodology: https://510kreport.com/methodology