# K190970: PROSTEP™ TBI™ (Tailors Bunion Implant) System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Aug 13, 2019 after 123 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: 5 generations back to K960385 (1996). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082320: Darco Small Screw, Wrightmedicaltechnologyinc (2008) Summary page 4.
- K132895: WMT Implantable K-Wire, Wrightmedicaltechnologyinc (2013) Summary page 4.
- K163039: ORTHOLOC® 3Di Small Bones Plating, Wrightmedicaltechnologyinc (2017) Summary page 4.

## Most influential descendants
- K262963: TMC Implant Fixation System (2026), 0 descendants of its own

## Indications for use
The PROSTEP™ TBI™ (Tailor’s Bunion Implant) system is indicated for the fixation of 5th metatarsal osteotomies made in the correction of Tailor’s Bunion.

Source page: https://510kreport.com/device/K190970
Methodology: https://510kreport.com/methodology