# K121349: IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and Washer

- Pathway: 510(k) (Special)
- Applicant: Extremity Medical, LLC
- Decided: Jul 18, 2012 after 75 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: 6 generations back to K962823 (1996). 16 ancestors in all.
12 later devices descend from it; 5 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101700: IO Fix Hand, IO Fix Foot, Extremity Medical Screw System, Extremity Medical, LLC (2010) Summary page 1.

## Most influential descendants
- K172260: Omni Foot Plating System (2017), 4 descendants of its own
- K180808: Omni Foot Plating System (2018), 3 descendants of its own
- K180257: InCore® Lapidus System (2018), 3 descendants of its own
- K212297: Omni Foot and Ankle Plating System (2021), 1 descendant of its own
- K192578: InCore TMT System (2019), 1 descendant of its own

## Indications for use
The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, anile, hand, aiid wrist. The two-part construct is specifically intended for Talonavicular Calcaneocuboid, Metatarsocuneiform, Anle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotomies.

Source page: https://510kreport.com/device/K121349
Methodology: https://510kreport.com/methodology