# K071540: Sbi Titanium Threaded Pin

- Pathway: 510(k) (Traditional)
- Applicant: Small Bone Innovations, Inc.
- Decided: Aug 8, 2007 after 64 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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 no predicate by number.

## Most influential descendants
- K151241: Synchro-Medical TIGER TRACK Screw System (2015), 0 descendants of its own

## Indications for use
The SBi Titanium Threaded Pin is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

Source page: https://510kreport.com/device/K071540
Methodology: https://510kreport.com/methodology