(90 days)
The ClearView™ Wrist Fixator is indicated for single use for fixation of distal fractures in upper extremity applications. This device provides alignment, reduction, and stabilization of fractures, corrective osteotomies, and soft tissue deformities. Common fractures indicated for this use:
- fractures of the wrist with ligamentous instability .
- comminuted intra-articular radius fractures
- post-traumatic reconstruction for joint stiffness .
- Colles Fracture .
- distal radius fractures (Types B and C) .
- Frykman Type III, IV, VII and VIII radius fractures
- any wrist fracture requiring distraction
The device is a preassembled, mechanically adjustable external fixator and is available in three sizes (small, medium, and large). It is a four-piece construct consisting of a radiolucent polycarbonate plastic and applied to the bone with 2 pairs, with the option of a third pair, of self-drilling half-pins measuring 3mm x 110mm both cancellous and cortical. The half pins are used as bone anchors and are manufactured from medical grade stainless steel (316LVM).
The provided text is a 510(k) premarket notification for the ClearView™ Wrist Fixator, a medical device. It describes the device, its intended use, and indicates its substantial equivalence to predicate devices already on the market.
However, the document does not contain any information regarding acceptance criteria, study design, reported device performance, sample sizes, expert qualifications, ground truth establishment, or clinical study results (such as MRMC studies or standalone performance).
Therefore, I cannot provide the requested table and information based on the given input. The 510(k) summary focuses on demonstrating substantial equivalence to already approved devices, which often relies on comparison of technical specifications and intended use rather than new clinical effectiveness studies with specific performance metrics and ground truth evaluations.
§ 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.