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K Number
K161048
Device Name
Conventus Orthopaedics Ulna Fixation System
Manufacturer
CONVENTUS ORTHOPAEDICS, INC.
Date Cleared
2016-07-26

(103 days)

Product Code
HRS,HSB
Regulation Number
888.3030
Type
Traditional
Panel
OR
Reference & Predicate Devices
K000684,K073402,K102689,K131552,K151379
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Conventus Orthopaedics Ulna Fixation System is indicated for treatment of distal or proximal ulna fractures when internal fixation is desired, and fracture fragments are not too numerous and/or too small to be stabilized with the use of the device.

Device Description

The Conventus Orthopaedics Ulna Fixation System is an intramedullary device intended for distal and proximal ulna fractures. The Ulna Fixation System is a self-expanding implant which is deployed into the medullary canal and provides a scaffold to which bone fragments are attached using fragment screws. The implant is made from titanium alloy (Ti-6Al-4V ELI) and Nitinol.

AI/ML Overview

This document is a 510(k) summary for the Conventus Orthopaedics Ulna Fixation System. It does not describe a study involving an AI/CADe/CADx device and human readers. Instead, it describes a medical device for fracture fixation and preclinical testing done to prove substantial equivalence to predicate devices. Therefore, I cannot extract the information requested as it is not present in the provided text.

§ 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.