(83 days)
Fixation of proximal and/or distal tibial fractures, with or without extension into the tibial shaft.
Synthes Hybrid External Fixator Modifications are components of the Synthes Hybrid External Fixator, a ring and wire based external fixator that forms a construct intended for the stabilization of complex proximal and/or distal tibial fractures. It is designed for use with the Synthes Large Exernal Fixator and may be used in conjunction with other fixation methods. The proposed components consist of an Adjustable Wire/Pin Clamp, a Low-Profile Adjustable Wire/Pin Clamp and Ring-To-Rod Clamp.
The provided text is a 510(k) summary for the Synthes (USA) Hybrid External Fixator Modifications device. It describes the device, its intended use, and its substantial equivalence to a predicate device.
However, the document does NOT contain information regarding:
- Acceptance criteria and reported device performance (Table 1)
- Study details (sample size, data provenance, expert numbers/qualifications, adjudication method, MRMC study, standalone performance, ground truth type, training set size, training set ground truth establishment).
The 510(k) summary focuses on demonstrating substantial equivalence based on the device's design, materials, and intended use being similar to a previously cleared device (Synthes Hybrid External Fixator, K950384). It is a regulatory submission, not a study report detailing performance metrics against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text. This type of information is typically found in design validation reports, clinical study reports, or detailed performance testing summaries, which are not part of this 510(k) public abstract.
§ 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.