# K082679: Laki Hand Fixation System, Model TFX.3X.06.X

- Pathway: 510(k) (Special)
- Applicant: Sintea Biotech, Inc.
- Decided: Apr 7, 2009 after 204 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: 1 generation back to K880282 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880282: Lima-Lto. Sem Modular External Stablizer, Lima-Lto, Inc. (1988) Summary page 1.

## Indications for use
The LAKI device is intended to be used for fixation of bone fractures of long bones in fingers. The LAKI device is a semi-invasive device intended to be attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Source page: https://510kreport.com/device/K082679
Methodology: https://510kreport.com/methodology