# K221645: PROstep (TM) MIS 5mm Chamfer Screw System

- Pathway: 510(k) (Abbreviated)
- Applicant: Wright Medical Technology
- Decided: Feb 17, 2023 after 256 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: 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™ MIS 5mm Chamfer Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: - Arthrodesis of the first metatarsal cuneiform joint to reposition and stabilize metatarsus primus varus - Calcaneus/cuboid arthrodesis - Talar/navicular arthrodesis

Source page: https://510kreport.com/device/K221645
Methodology: https://510kreport.com/methodology