(22 days)
The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavilce, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia. and fibula.
The Acumed Scapula Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium in conformance with ASTM F67 and ASTM F136 and stainless steel in conformance with ASTM F138 and ASTM F2229. Plates and screws are provided non-sterile.
The Acumed Congruent Bone Plate System is a medical device and the provided 510(k) summary explicitly states: "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable."
Therefore, based on the provided document, there is no information available regarding acceptance criteria or a study that proves the device meets acceptance criteria.
The device obtained substantial equivalence based on its technological characteristics and intended use being similar to legally marketed predicate devices, not on specific performance data or a study demonstrating meeting acceptance criteria.
§ 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.