(108 days)
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
RIVAL™ View Plating System™ and Reduce Fracture Plating System™ has been designed to support multiple indications within the forefoot and mid-foot. The Subject device introduces new line extension codes, in sterile and non-sterile configuration. Subject device is manufactured by the same material (Ti6Al4V) and by the same manufacturer Orthofix Srl as the predicate EDGE Orthopaedics VIEW and REDUCE Plating System.
This document is a 510(k) summary for the RIVAL™ View Plating System™ and Reduce Fracture Plating System™. It does not describe an AI/ML device or a study involving such. The document pertains to metallic bone fixation appliances and accessories, which are physical medical devices.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth related to an AI/ML device. The document mentions "Performance Analysis" in which "Mechanical performance and engineering assessment with worst case of subject device and corresponding predicate devices, confirm that subject devices have equivalent or better strength and resistance." This indicates a traditional engineering assessment for a physical medical device, not an AI/ML performance study.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.