(69 days)
The R-X-Fix external fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies.
The R-X-Fix External Fixator is a stable solution for fractures and for lengthening of small bones. The R-X-Fix External Fixator is hinged to allow adjustment in horizontal or vertical axis and is used for comminuted intra-articular fractures, joint stiffness, or arthrodesis of the foot or hand. The hinge system allows range of motion at the joint during treatment. The design allows the placement of pins to be adjusted around three orthogonal axes and translated linearly.
This document describes a 510(k) submission for the R-X-Fix External Fixator, a medical device. It does not contain information about acceptance criteria or a study proving device performance against such criteria.
The provided text does not include any information regarding acceptance criteria, device performance metrics, or any study conducted to demonstrate the device meets specific criteria. The document is a 510(k) summary and the FDA's clearance letter, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against quantified acceptance criteria through a clinical or non-clinical study.
Specifically:
- There is no table of acceptance criteria or reported device performance.
- No sample size for test sets or data provenance is mentioned.
- No information about experts, adjudication methods, or MRMC studies is present.
- Standalone algorithm performance is not applicable as this is a mechanical device.
- No ground truth type is mentioned.
- No training set size or ground truth establishment for a training set is provided.
The document indicates "Non-clinical Testing None," which further confirms the absence of performance data from a study. The 510(k) clearance is based on substantial equivalence to predicate devices (Orthofix Dynamic Axial Fixation system and Fixano Minifix Fixator), rather than demonstrating specific performance metrics.
§ 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.