# K012294: Wristore Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Millennium Medical Technologies, Inc.
- Decided: Mar 4, 2002 after 227 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K942906 (1994). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003397: Colles C Series Frame Sterile Pack, DePuy Orthopaedics, Inc. (2001) Summary page 1.
- K984498: Synthes (Usa) Articulating Distal Radius (Adrf) System, Synthes (Usa) (1999) Summary page 1.

## Most influential descendants
- K042761: Wristore Distal Radius Fracture Fixator, 4600 Series (2004), 1 descendant of its own
- K101338: Newfix External Fixation System (2011), 0 descendants of its own
- K052498: Fragment Specific Fixator (2005), 0 descendants of its own

## Indications for use
The Wristore Fixator is intended to provide external fixation of the upper extremity. External fixation devices allow for three plane (axial, AP & medio/lateral) control over fractures and bone segments.

Source page: https://510kreport.com/device/K012294
Methodology: https://510kreport.com/methodology