(78 days)
Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
The Synthes Condylar Head Add-on System is an adjustable height add-on system for use with the 2.4 mm Locking Reconstruction Plate System and MatrixMANDIBLE Plate System. It consists of a condylar head, 2 screws, and one of four (4) fixation plates, each with a different screw hole spacing that determines the height of the condylar head.
The provided documents do not contain information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, adjudication methods, or MRMC comparative effectiveness studies.
The documents are a 510(k) summary and an FDA clearance letter for the "Synthes (USA) Condylar Head Add-on-System - Modification". These documents focus on establishing substantial equivalence to a predicate device, an existing Synthes Condylar Head Add-on-System.
Specifically, the 510(k) summary states that "Documentation is provided which demonstrates the Synthes (USA) Condylar Head Add-on-System - Modification to be substantially equivalent to other legally marketed devices such as: Synthes (USA) Condylar Head Add-on-System." This implies that the device's acceptance is based on its similarity to an already approved device, rather than a new study proving specific performance metrics against defined acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
§ 872.4770 Temporary mandibular condyle reconstruction plate.
(a)
Identification. A temporary mandibular condyle reconstruction plate is a device that is intended to stabilize mandibular bone and provide for temporary reconstruction of the mandibular condyle until permanent reconstruction is completed in patients who have undergone resective surgical procedures requiring removal of the mandibular condyle and mandibular bone. This device is not intended for treatment of temporomandibular joint disorders.(b)
Classification. Class II (special controls). The special controls for this device is FDA's guideline entitled “Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline.” See § 872.1(e) for the availability of this guidance document.