# K081934: Extremity Medical Compression Screw

- Pathway: 510(k) (Traditional)
- Applicant: Extremity Medical, LLC
- Decided: Aug 29, 2008 after 53 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: 3 generations back to K962823 (1996). 9 ancestors in all.
68 later devices descend from it; 4 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050636: Synthes 3.0MM Headless Compression Screws, Synthes (Usa) (2005) Summary page 1.
- K993762: I.CO.S Screw, New Deal, S.A. (2000) Summary page 1.
- K024233: Kompressor Screw System, Kinetikos Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- K082934: Extremity Medical Midfoot Screw System (2009), 63 descendants of its own
- K101700: IO Fix Hand, IO Fix Foot, Extremity Medical Screw System (2010), 56 descendants of its own
- K171018: Axis Charcot Fixation System, 4.5 to 8.5mm Screw System (2017), 24 descendants of its own
- K142581: APTUS Foot System (2015), 22 descendants of its own
- K190586: Monster® Screw System (2019), 21 descendants of its own

## Indications for use
The Extremity Medical Compression Screw is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunions of the small bones and joints of the foot and hand. Examples include scaphoid fractures, tarsal and metatarsal fracture, hand, wrist, foot and ankle arthrodeses, metacarpal and metatarsal arthrodeses, distal radius fractures.

Source page: https://510kreport.com/device/K081934
Methodology: https://510kreport.com/methodology