# K223392: REVCON (TM) Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Voom Medical Devices, Inc.
- Decided: Feb 28, 2023 after 112 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 REVCON™ Screw System is indicated for fixation of bone surgery involving 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 • Akin type osteotomy • Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus • Calcaneus/cuboid arthrodesis • Talar/navicular arthrodesis. The REVCON™ Screw System is not intended for spinal use.

Source page: https://510kreport.com/device/K223392
Methodology: https://510kreport.com/methodology