(63 days)
Unstable fractures of the distal radius: intra-articular, extra-articular, and preliminary fixation before internal fixation. Fractures and fracture dislocations of the hand, wrist, forearm, mandible, foot, ankle, and long bones; joint fusion, osteotomies, and peri-articular fractures.
TransFx Small External Fixation System, TransFx Intermediate External Fixation System, TransFx Mini External Fixation System
This document is not a study, but rather a letter from the FDA to a medical device manufacturer, Immedica, Inc., regarding their 510(k) premarket notification for the TransFx External Fixation Systems.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided text.
The document states that the FDA has determined the device is "substantially equivalent" to predicate devices, allowing it to be marketed. This determination is based on the information submitted in the 510(k) notification, which would have included performance data, but that specific data and the acceptance criteria used are not detailed in this letter itself.
§ 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.