# K170889: HV Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Apr 26, 2017 after 33 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The HV 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 * 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 * Talar/navicular arthrodesis

Source page: https://510kreport.com/device/K170889
Methodology: https://510kreport.com/methodology