(64 days)
Synthes Distal Radius Plate System is intended for fixation of fractures, osteotomies, including carpal fusions involving the distal radius applied to the volar and dorsal aspect.
The Distal Radius Plate System consists of volar and dorsal plates, 2.4 mm cortex screws, and 1.8 mm threaded-head buttress pins. The volar plate is T-shaped, precontoured, and has six threaded screw holes. The dorsal plate is shaped like the Greek letter Pi, precontoured, and has six internally threaded screw holes in the head. Both plates are available in right and left versions; accept cortex screws (2.7 mm and 2.4 mm) and 1.8 mm threaded-head buttress pins; and can be cut to size.
The provided text is a 510(k) Summary for the Synthes (USA) Distal Radius Plate System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a formal study with detailed statistical outcomes.
Therefore, the document does not contain the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes, provenance of data, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results.
The document primarily focuses on:
- Device Description: The physical characteristics of the plates and screws.
- Intended Use: Fixation of fractures and osteotomies involving the distal radius.
- Material: Stainless Steel and Titanium alloy for plates, Titanium and Stainless Steel for screws.
- Predicate Devices: Synthes Dorsal Distal Radius Plate System (K962616) and Synthes Ti Alloy Volar Distal Radius Plate System (K963798).
The FDA's letter (K982732) confirms that the device is substantially equivalent to legally marketed predicate devices, which allows it to be marketed. This regulatory pathway does not typically involve the detailed study design and acceptance criteria reporting you've outlined.
§ 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.