(27 days)
The A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is to be used for external stabilization of open and/or unstable fractures of the distal radius were soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of external fixation.
A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is an external wrist fixator made of titanium , consisting of two (distal and proximal) connecting slide sections with predetermined angled holes. Standard Kirschner wires (K-wire) are inserted through the predetermined angle holes for fracture fixation, three on the distal section and two on the proximal section. The sections can be adjusted distal to proximal and locked into place by way of a center hex screw. The device will be offered sterile and is single use.
The provided text is a 510(k) summary for a medical device (A.M. Surgical CPF Distal Radial External Cross Pin Fixation System) and a clearance letter from the FDA. It does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot provide the requested information from the given input.
The document primarily focuses on:
- Device Description: What the device is and its components.
- Intended Use: For what medical conditions and anatomical location the device is used.
- Predicate Device Comparison: How it compares to previously cleared devices to establish substantial equivalence.
- Regulatory Classification: Its class and product code by the FDA.
- FDA Clearance Letter: Official communication from the FDA confirming clearance.
There is no mention of any performance study, clinical trial data, or specific acceptance criteria for performance other than the device being "substantially equivalent to the predicate and is safe and effective for its intended use" based on design and intended use comparison.
§ 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.