(88 days)
Synthes 2.4 mm Cannulated Compression Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodeses, including, but not limited to, scaphoid fractures; intra-articular fractures of the tarsals, metatarsals, carpals and metacarpals; bunionectomies and osteotomies; arthrodeses of small joints (e.g. phalanges); fractures of the patella, ulna and radial styloid.
Synthes 2.4 mm Cannulated Compression Screw is a partially threaded self-tapping and self-drilling screw that can be guided into a position using a guidewire. The threaded head is designed to be recessed below or sit flush with the near cortex and features a StarDrive™ head. Synthes 2.4 mm Cannulated Compression Screws are available in various lengths.
This document describes a medical device, the Synthes 2.4 mm Cannulated Compression Screw, and its substantial equivalence to a predicate device. It does not contain information on acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, ground truth establishment, or any studies (MRMC or standalone AI performance).
Therefore, I cannot provide the requested information. The provided text is a 510(k) summary and FDA clearance letter, which outlines the device's classification, predicate device, intended use, and materials but does not include clinical study data or performance metrics in the format requested for AI/software-based devices.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.