(23 days)
The Merete BLP™ Small Fragment Locking Bone Plate System is used for adult and pediatric patients as indicated for small bone fracture fixation. Indications for use include fixation of fractures, osteotomies, non-unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.
Not Found
This document is an FDA 510(k) clearance letter for the Merete BLP™ Small Fragment Locking Bone Plate System. It explicitly states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, the letter does not describe any acceptance criteria or a study proving the device meets those criteria, as these are typically part of a device's submission which is not provided here. The 510(k) process for this type of device does not usually require clinical trials with human subjects or detailed performance studies against specific acceptance criteria in the same way a new, high-risk device might.
The letter focuses on regulatory clearance based on substantial equivalence to existing devices.
Based on the provided text, none of the requested information regarding acceptance criteria or a study that proves the device meets them can be extracted.
The document only serves as regulatory clearance and states the intended use and indications for the device.
§ 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.