(160 days)
The Orthofix Galaxy Wrist external fixator is an orthopedic device intended to be used for bone stabilization in trauma and orthopedic procedures, both on adults and pediatric patients as required.
The indications for use include:
- intra-articular or extra-articular fractures and dislocations of the wrist with or without soft tissue damage:
- polytrauma;
- carpal dislocations;
- unreduced fractures following conservative treatment;
- bone-loss or other reconstructive procedures:
- infection.
The Orthofix Galaxy Wrist is a complimentary system for the current Galaxy Fixation system, engineered specifically for the wrist. The primary objective of the Galaxy Wrist is to offer the possibility of distraction/compression and the mobilization of the joint. The device includes various frames, bars, clamps, accessories and instruments. The system is designed to be used with commercially available Orthofix pins. The clamps enable the frame to be coupled to bone by securing the pins/wires for the intended use. The system allows the surgeon to: - Position screws where the condition of the bone and soft tissues permits - Reduce the fracture in order to restore alignment
This is a 510(k) premarket notification for a medical device (Orthofix Galaxy Wrist external fixator), not a study evaluating an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design, expert consensus, and training/test set details for an AI model is not present in the provided document.
The document describes the device's indications for use, technological characteristics, and performance data related to mechanical testing and MRI compatibility, demonstrating substantial equivalence to predicate devices. It explicitly states that "Clinical data was not needed to support the safety and effectiveness of the Subject Device."
Therefore, I cannot provide the requested information.
§ 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.