# K150871: ForeFoot STP System

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Aug 4, 2015 after 125 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 11 generations back to K962616 (1996). 76 ancestors in all.
No later device cites it as a predicate yet.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014154: Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone Screws DB1 Thread,Model F20-XX-00, Vilex, Inc. (2002) Summary page 4.
- K052576: Sbi Autofix, Small Bone Innovations, LLC (2005) Summary page 4.
- K131324: Maxtorque Screw System, Orthohelix Surgical Designs, Inc. (2013) Summary page 4.
- K053394: Nexa Bone Screw System, Nexa Orthopedics, Inc. (2005) Summary page 4.

## Indications for use
The Tornier ForeFoot STP Screw System is indicated for fixation of fractures, fusions, and osteotomies of bones of the hand and foot.

Source page: https://510kreport.com/device/K150871
Methodology: https://510kreport.com/methodology