# K042066: Klsa Martin Hand Distractor

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Aug 25, 2004 after 23 days
- Product code: JEC (Component, Traction, Invasive)
- 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: 4 generations back to K792561 (1979). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973275: KLS-Martin Intraoral Distractor, KLS-Martin L.P. (1997) Summary page 1.
- K983515: KLS Intraoral Vertical Distractor, KLS-Martin L.P. (1998) Summary page 1.
- K971755: Hoffmann II Compact External Fixation System, Howmedica Corp. (1997) Summary page 1.
- K965029: Stableloc II External Fixator, Acu Med, Inc. (1997) Summary page 1.

## Indications for use
The KLS Martin Hand Distractor is designed to be used in finger reconstruction of the thumb or the metacarpal bones I - IVafter amputation or malformation.

Source page: https://510kreport.com/device/K042066
Methodology: https://510kreport.com/methodology