(59 days)
The EVOS Wrist Plating System is indicated for adult and pediatric patients with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna.
Subject of this premarket notification is the EVOS Wrist Fragment Plating System. The proposed devices incorporate design features that are currently incorporated on previously cleared Smith & Nephew bone plate and screw systems. Like their previously cleared counterparts, the proposed plates feature a screw-to-plate locking feature that permits their use with the proposed and compatibility designed locking and non-locking cortex screws described in this premarket notification. Each screw hole contains five separate tabs that engage with the threads of the locking screw. The locking screws can be angled and locked up to fifteen degrees in any direction, allowing for custom, multi-directional locked plating constructs. The subject plates can be used with screws previously cleared via K161665, K132296, K993106, K162078, K140814 and K132886 and pegs subject of this premarket notification.
This document describes the submission for the EVOS Wrist Fracture Plating System and does not contain information related to software or AI/ML acceptance criteria or studies. Instead, it focuses on the substantial equivalence of a medical device (bone plating system) to previously cleared predicate devices.
Therefore, I cannot provide the requested information about acceptance criteria and studies proving the device meets those criteria, as it pertains to AI/ML devices. The document details mechanical testing, packaging verification, bacterial endotoxin testing, and biocompatibility testing for a physical implantable device, not a software algorithm.
§ 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.