(54 days)
Normed Titanium Rondo Fix Fusion Plate and Screw System intended for wrist arthrodesis, providing fixation of small bones such as the radius and carpal bones, patients suffering pain and/or loss of function due to osteoarthritis, post traumatic arthritis, fractures, revision of failed wrist fusions, segmental bone loss, rheumatoid arthritis and tumor resection. The system can be used in both adult and pediatric patients.
Normed Titanium Rondo Fix Fusion Plate and Screw System consists of a series of convex/concave plates in various shape and length which are attached to the bone using screw fixation. The plates are available in 1.0 mm plate thickness and can be contoured as needed to fit the specific anatomy. The self-tapping 2.3 mm screw diameters will be available in two screw head designs, standard cross-lock and square lock.
This document is a 510(k) summary for a medical device. It does not include information about acceptance criteria or a study proving the device meets said criteria. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text.
The document discusses the device name, intended use, classification, and regulatory status (specifically, substantial equivalence to a predicate device). It's a premarket notification, indicating that the device is being cleared for market based on its similarity to existing cleared devices, rather than through a new clinical trial demonstrating specific performance metrics against pre-defined acceptance criteria.
Thus, all sections of your request remain unanswerable from the provided text, as they pertain to performance testing and evaluation, which is not present in this regulatory submission.
§ 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.