# K033406: Small Bone Fixation System

- Pathway: 510(k) (Special)
- Applicant: Hand Innovations, Inc.
- Decided: Jan 15, 2004 after 83 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: 2 generations back to K991064 (1999). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994232: Phalangeal Fixation System, Medcanica, Inc. (2000) Summary page 1.
- K013424: Intramedullary Fixation System for the Hand, Hand Innovations, Inc. (2001) Summary page 1.

## Most influential descendants
- K211439: Small Bone Nailing System (2021), 0 descendants of its own

## Indications for use
The Small Bone 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.

Source page: https://510kreport.com/device/K033406
Methodology: https://510kreport.com/methodology