# K082934: Extremity Medical Midfoot Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Extremity Medical, LLC
- Decided: Apr 23, 2009 after 204 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: 4 generations back to K962823 (1996). 14 ancestors in all.
63 later devices descend from it; 5 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)
- K050683: Synthes (Usa) 3.5MM Conical Screws, Synthes (Usa) (2005) Summary page 1.
- K081934: Extremity Medical Compression Screw, Extremity Medical, LLC (2008) Summary page 1.
- K022726: Stayfuse GT-IP, Pioneer Surgical Technology (2002) Summary page 1.
- K081071: Synthes 6.5MM Midfoot Fusion Bolt, Synthes (Usa) (2008) Summary page 1.

## Most influential descendants
- 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
- K162674: BioPro Foot Plating Systems (2017), 19 descendants of its own

## Indications for use
The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints.

Source page: https://510kreport.com/device/K082934
Methodology: https://510kreport.com/methodology