(77 days)
The Merete Locking Bone Plate System can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes.
The Merete Locking Bone Plate System II consists of contoured, anatomically shaped locking bone plates in various sizes and different curvatures for Merete 3.0mm and 3.5mm locking screws (K081513) and cannulated 3.0mm compression screws (K090063). The system is made of titanium alloy Ti-6Al-4V and unalloyed titanium.
This document is a 510(k) summary for the Merete Locking Bone Plate System II. It describes a medical device, specifically a bone plate system, and its intended use. There is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text.
The document focuses on:
- Identifying the device and its manufacturer.
- Listing predicate devices to establish substantial equivalence.
- Describing the device's materials and technological characteristics (stating they are similar to predicate devices).
- Stating its intended use (fixation of fractures, revision procedures, etc., in small bones).
- Providing FDA correspondence regarding its 510(k) clearance.
Therefore, I cannot provide the requested table and study details as they are not present in the given input.
§ 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.