# K162353: MICATM Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Apr 13, 2017 after 233 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: 1 generation back to K082320 (2008). 1 ancestor in all.
33 later devices descend from it; 9 cite it directly.
0 of 35 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.

## Most influential descendants
- K190586: Monster® Screw System (2019), 21 descendants of its own
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System (2020), 9 descendants of its own
- K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System (2023), 8 descendants of its own
- K203011: Monster Screw System (2020), 6 descendants of its own
- K231262: Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System (2023), 4 descendants of its own

## 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/K162353
Methodology: https://510kreport.com/methodology