# K201556: Intraosseous Fixation System

- Pathway: 510(k) (Special)
- Applicant: Extremity Medical, LLC
- Decided: Jul 8, 2020 after 28 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: 13 generations back to K962616 (1996). 96 ancestors in all.
No later device cites it as a predicate yet.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121349: IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and Washer, Extremity Medical, LLC (2012) Summary page 4.
- K101700: IO Fix Hand, IO Fix Foot, Extremity Medical Screw System, Extremity Medical, LLC (2010) Summary page 4.
- K171018: Axis Charcot Fixation System, 4.5 to 8.5mm Screw System, Extremity Medical, LLC (2017) Summary page 4.
- K124027: Monster Screw System, Apogee Orthosolutions (2013) Summary page 4.

## Indications for use
The Intraosseous Fixation System 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 hand, wrist, foot and ankle, appropriate for the size of the device.

Source page: https://510kreport.com/device/K201556
Methodology: https://510kreport.com/methodology