# K190388: RIVAL View Plating Systems and Reduce Fracture Plating Systems

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Jun 7, 2019 after 108 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K022325 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140876: View Plating System,Reduce Fracture Plating System,Bone Screw, Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic (2014) Summary page 4.

## Indications for use
RIVAL™ View Plating System™ and Reduce Fracture Plating System™ are intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with Rival locking and non-locking bone screws. Plates and screws are intended for single use only. Screws are not intended for use in the spine. Examples of these procedures for which the RIVAL™ View Plating Systems™ may be used, but are not limited to: » First metatarsal osteotomies for hallux valgus correction including: - Opening base wedge osteotomy - Closing base wedge osteotomy - Crescentic osteotomy - Proximal Chevron osteotomy - Distal Chevron osteotomy (Austin) » First metatarsal fracture fixation * Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion) » Arthrodesis of the first metatarsophalangeal joint (MTP) including: - Primary MTP Fusion due to hallux rigidus and/or hallux valgus - Revision MTP Fusion - Revision of failed first MTP Arthroplasty Implant Calcaneal-Cuboid Fusion » Talonavicular Fusion * Evans Osteotomy Example of indications for which the RIVAL™ Reduce Plating Systems™ may be used, but are not limited to: * Metatarsal or metacarpal fractures and osteotomies * Phalanges fractures and osteotomies * Lapidus Fusion » Lisfranc Arthrodesis * 1st MPJ Arthrodesis » Forefoot osteotomies

Source page: https://510kreport.com/device/K190388
Methodology: https://510kreport.com/methodology