(56 days)
External fixation devices are used on adults or pediatric patients as required. External fixation systems consist of various components that are used to build fixator assemblies unique to the patient's needs. These devices are modular therefore, a multitude of different fixator frame configurations are possible. External fixation devices are used for the following indications:
- Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
- Open and closed fracture fixation
- Pseudoarthrosis of long bones
- Limb lengthening by distraction (not applicable for use with COMPASS Universal Hinge)
- Correction of bony or soft tissue deformities (not applicable for use with COMPASS Universal Hinge).
- Joint arthrodesis (not applicable for use with COMPASS Universal Hinge)
- Infected fractures
- Nonunions
The indications for use listed above cover many of the external fixation systems marketed by Smith & Nephew. These indications are similar to the indications of the predicate devices. The device is intended for single use.
The subject of this Traditional 510k is the Circular Fixation with Balanced Cable Transport. Originally, the subject device was identified as the ILIZAROV with Balanced Cable Transport. It has since been decided as a company's decision to change the name of the subject device to Circular Fixation with Balanced Cable Transport. In addition, there was an update to the indications for use language since the Pre-Submission. The subject Circular Fixation with Balanced Cable Transport is a product line addition to the predicate, ILIZAROV Pulley System. The Circular Fixation with Balanced Cable Transport consists of cables, pulleys, and the new subject devices, the struts. The existing cables and pulleys are cleared on a similar external fixation system, the predicate ILIZAROV Pulley System, via premarket notification K042436 S.E. 10/07/2004. In the subject, Circular Fixation with Balanced Cable Transport, the cable is routed through the bone segment and exits through soft tissue. Cables are available in diameter of 1.8mm and a length of 1200mm. The subject telescopic rod or a modified strut acting as a motor is attached to the ring-based circular fixation construct. The subject device is turned to pull the cable and move the bone segments in order to perform bone transport and limb lengthening. The advantages of using the subject Circular Fixation with Balanced Cable Transport, include the ability to use fewer half pins and wires. Fewer half pins and wires will create less soft tissue disruption, eliminating the need to pull pins and wires through the skin and soft tissue as the bone moves.
The provided document is a 510(k) summary for a medical device called "Circular Fixation with Balanced Cable Transport." This document focuses on demonstrating substantial equivalence to a predicate device based on material, intended use, and performance characteristics through bench testing. It does not describe a clinical study involving AI assistance, multi-reader multi-case studies, or the establishment of ground truth by expert consensus or pathology for an image-based diagnostic device.
Therefore, the requested information regarding acceptance criteria and performance for an AI-based device, including sample sizes, expert involvement, and clinical study methodologies, cannot be extracted from this document. The document pertains to a mechanical orthopedic device.
§ 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.