(78 days)
Synthes Ratcheting Distractor is intended for craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the mandible and maxilla. Specifically, it is indicated for correcting deficiencies in craniofacial bones, especially orthognathic mandible lengthenings.
The Synthes Ratcheting Distractor is an intra-oral distraction device. It features two telescoping components, with contoured legs that have threaded screw holes, that are fixed to bone via 1.3 mm - 3.0 mm screws. The distractor is available in right and left versions; has a ratcheting mechanism that is activated by an "activation instrument"; and is capable of distraction lengths of up to 30 mm. It is manufactured from a titanium alloy.
The provided document is a 510(k) summary for the Synthes Ratcheting Distractor, a medical device. This type of document is for regulatory clearance of a new device based on its substantial equivalence to a legally marketed predicate device.
It describes the device itself, its intended use, and identifies a predicate device. However, it does not contain the information requested in your prompt regarding acceptance criteria, performance studies, sample sizes, expert involvement, or any form of AI/algorithm performance.
Therefore, I cannot provide the requested information based on the text provided.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.