# K183620: PROSTEP TBC Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jun 6, 2019 after 162 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K082320 (2008). 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)
- K162353: MICATM Screw System, Wrightmedicaltechnologyinc (2017) Summary page 4.

## Indications for use
The PROSTEP TBC Implant System is indicated for bone reconstruction. Examples include: • Bi-Cortical osteotomies in the foot • Distal metatarsal osteotomies • Fixation of osteotomies for Hallux Valgus treatment (such as Transverse, Chevron, etc.)

Source page: https://510kreport.com/device/K183620
Methodology: https://510kreport.com/methodology