# K994232: Phalangeal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Medcanica, Inc.
- Decided: Mar 1, 2000 after 76 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 its predicate without a number.
- (no number) K-wire implantable pin manufactured and marketed by MicroAire Surgical Equipment, Inc.: named in the summary without a submission number

## 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 Phalangeal Fixation System is indicated for the fixation of transverse or short oblique fractures of proximal phalanx of the fingers.

Source page: https://510kreport.com/device/K994232
Methodology: https://510kreport.com/methodology