# K081011: Arex Scru 2 Headless Compression Screws, Models: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45

- Pathway: 510(k) (Traditional)
- Applicant: Arex USA
- Decided: Nov 7, 2008 after 212 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 K792022 (1979). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792022: Herbert Bone Screw, Zimmer, Inc. (1979) Summary page 1.
- K050636: Synthes 3.0MM Headless Compression Screws, Synthes (Usa) (2005)

## Most influential descendants
- K200259: Headless Compression Screw System (2020), 0 descendants of its own

## Indications for use
The AREX SCRU2 headless compression screw is intended for fixation of intra-articular and extra-articular fractures of the upper and lower extremities, as well as non-unions of small bones and bone fragments, arthrodesis of small joints, bunionectomies and osteotomies. Examples include scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

Source page: https://510kreport.com/device/K081011
Methodology: https://510kreport.com/methodology