(154 days)
The GRAVITY™ Syndesmosis LP System is intended to provide fixation during the healing process following trauma to the Ankle Syndesmosis (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for ankle fractures such as Weber B and C.
The subject GRAVITY™ Syndesmosis LP is a sterile, single-use, device intended to stabilize syndesmotic trauma of the ankle. The subject system consists of UHMWPE suture tensioned between two titanium alloy buttons.
This document is a 510(k) summary for a medical device called GRAVITY™ Syndesmosis LP. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe acceptance criteria, a study proving the device meets acceptance criteria, or any performance metrics, sample sizes, or expert involvement as requested.
Therefore, I cannot provide the requested information based on the provided text. The document states that "Performance testing and analysis demonstrated substantial equivalence in side by side construct static and dynamic tensile testing" and "Bacterial endotoxin levels on the final finished form of the device were evaluated using LAL pyrogen testing," but it does not provide any details on the acceptance criteria or results of these tests. It also explicitly states "N/A" for clinical evidence.
§ 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.