(27 days)
For wrist arthrodesis and for fractures of other small long bones such as the clavicle and olecranon. Specific indications include post-traumatic arthritis of the joints of the wrist; rheumatoid wrist deformities requiring restoration; complex carpal instability, post-septic arthritis of the wrist; severe unremitting wrist pain related to motion; brachial plexus nerve palsies; turnor resection; and spastic deformities. Single use device for cementless use only.
These anatomically contoured plates are offered in two lengths (standard or short), manufactured from either titanium (ASTM F-136) or stainless steel (ASTM F-138 or ASTM F-2229). The plate contains a single row of screw holes (2.4mm, 2.7mm and 3.2mm in diameter) down its length. The locking screws are 2.4mm in diameter and vary in length from 6mm to 14mm. The 2.7mm and 3.2mm screws were previously cleared. In addition to the screws, the device utilizes a press fit intramedullary fixation for the proximal stem.
This is not an AI/ML device. This is a 510(k) premarket notification for a medical device called "Wrist Fusion Plate". The document does not contain information about acceptance criteria or a study proving the device meets them because it is a traditional medical device, not an AI/ML product. Therefore, it is unable to answer the question as it pertains to AI/ML device testing and evaluation.
§ 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.