# K022065: Sintea Biotech Traumafix System, Model TFX.00.00.X

- Pathway: 510(k) (Traditional)
- Applicant: Sintea Biotech, Inc.
- Decided: Aug 6, 2002 after 42 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Lima-Lto External Circular Stabilizer (ECS): named in the summary without a submission number

## Indications for use
The Sintea Biotech Traumafix System is indicated for use in the following conditions: Fracture Limb lengthening Reconstruction Traction

Source page: https://510kreport.com/device/K022065
Methodology: https://510kreport.com/methodology