(90 days)
The Synthes High Tibial Osteotomy Plate is intended for closing wedge high tibial osteotomies for treatment of bone and joint deformities and misalignment caused by injury or disease such as osteoarthritis.
The Synthes High Tibial Osteotomy Plate is a flat, triangle shaped metal plate, that works as a tension band utilizing traditional internal plate/screw fixation.
This document is a 510(k) premarket notification for the "Synthes High Tibial Osteotomy Plate," a medical device used for bone fixation. The provided text does not include any information about acceptance criteria or a study proving that the device meets such criteria.
The document focuses on:
- Device Identification: Name, classification, and contact information.
- Substantial Equivalence: The primary basis for clearance, stating that it's substantially equivalent to a legally marketed predicate device. This means the FDA found it to be as safe and effective as a device already on the market, without requiring new clinical trials to prove its performance against specific acceptance criteria.
- Device Description: A brief explanation of its form and function.
- Indications for Use: The specific medical conditions and procedures for which the device is intended.
- Material: Stainless Steel.
- FDA Communication: The letter from the FDA confirming the 510(k) clearance based on substantial equivalence and outlining regulatory responsibilities.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as none of this information is present in the provided text.
§ 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.