# K031154: Sintea Biotech Schanz Screw, Model TFX.SS.XX.X

- Pathway: 510(k) (Traditional)
- Applicant: Sintea Biotech, Inc.
- Decided: Jun 24, 2003 after 74 days
- Product code: JDW (Pin, Fixation, Threaded)
- 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 K861766 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011136: Apex Fixation Pins, Howmedica Osteonics Corp. (2001)
- K861766: Howmedica Hoffmann Fixation Pin System, Howmedica Corp. (1986) Summary page 2.

## Indications for use
The Sintea Biotech external fixation screw is indicated for use in the external fixation of bone.

Source page: https://510kreport.com/device/K031154
Methodology: https://510kreport.com/methodology