(27 days)
The Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. "red-red" and "red-white" zones) in conjunction with immobilization during healing.
The device description of the Meniscus Arrow™ is as follows.
- Composed of poly-L/D-polylactide copolymer
- Length 10, 13 and 16mm
- Diameter 1.1mm
The dimensions and shape are completely identical with the Biofix® Biodegradable Meniscus Arrow System (K955768).
The provided text is a 510(k) summary for the Bionx Implants Inc. Meniscus Arrow™ and an FDA clearance letter. It clearly states the device's intended use and describes its similarities to a predicate device, the Biofix® Biodegradable Meniscus Arrow System (K955768).
However, this document does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, adjudication methods, or specific details about training or test sets. Instead, the clearance for Meniscus Arrow™ is based on its substantial equivalence to the predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets them from the provided text. The document focuses on demonstrating that the new Meniscus Arrow™ is fundamentally the same as its already-cleared predecessor.
§ 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.