# K041157: Modification to Small Bone Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Hand Innovations, Inc.
- Decided: Jul 30, 2004 after 88 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K111663: Trauma Internal Fixation Systems (2012), 1 descendant of its own
- K243761: A.L.P.S. Small Fragment Plating System (2025), 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, and the metatarsal bones of the foot.

Source page: https://510kreport.com/device/K041157
Methodology: https://510kreport.com/methodology