# K013424: Intramedullary Fixation System for the Hand

- Pathway: 510(k) (Traditional)
- Applicant: Hand Innovations, Inc.
- Decided: Dec 20, 2001 after 66 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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: 1 generation back to K991064 (1999). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991064: Metacarpal Fixation System, Medcanica, Inc. (1999) Summary page 1.

## Most influential descendants
- K033406: Small Bone Fixation System (2004), 1 descendant of its own
- K211439: Small Bone Nailing System (2021), 0 descendants of its own

## Indications for use
The Intramedullary Fixation System is indicated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges. The optional locking device may be used to minimize axial and rotational motion of the implantable nail during healing.

Source page: https://510kreport.com/device/K013424
Methodology: https://510kreport.com/methodology