# K101700: IO Fix Hand, IO Fix Foot, Extremity Medical Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Extremity Medical, LLC
- Decided: Oct 12, 2010 after 117 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K962823 (1996). 15 ancestors in all.
56 later devices descend from it; 4 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081934: Extremity Medical Compression Screw, Extremity Medical, LLC (2008) Summary page 1.
- K962823: Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer, Synthes (Usa) (1996) Summary page 1.
- K082934: Extremity Medical Midfoot Screw System, Extremity Medical, LLC (2009) Summary page 1.

## Most influential descendants
- 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
- K121349: IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and Washer (2012), 12 descendants of its own
- K193222: Tyber Medical Anatomical Plating System (2020), 11 descendants of its own

## Recalls of this device
- Mar 22, 2012 · Class II · Z-0752-2013: Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant 
- Apr 13, 2011 · Class II · Z-0344-2013: Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.

## 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, ankle, hand, and wrist. The two-part construct is specifically intended for Talonavicular, Calcanealcuboid, Metatarso-Cunieform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotemies,

Source page: https://510kreport.com/device/K101700
Methodology: https://510kreport.com/methodology