# K181377: PROSTEP MICA Screw System

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jan 11, 2019 after 232 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 MICA™ Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: Mono or Bi-Cortical osteotomies in the foot or hand Distal or Proximal metatarsal or metacarpal osteotomies Weil osteotomy Fusion of the first metatarsophalangeal joint and interphalangeal joint Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) Akin type osteotomy Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus Calcaneus/cuboid arthrodesis Talar/navicular arthrodesis

Source page: https://510kreport.com/device/K181377
Methodology: https://510kreport.com/methodology