|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM|
|Classification Name||joint, temporomandibular, implant|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the bone screw length to match the labeled lengths, to standardize the screw thread profile and pitch, to increase the length of the threaded portion of the bone screw, to round the tip of the screw, to add a fillet between the screw head and screw shaft, to standardize dimensions of certain geometrical features of the bone screws (the screw head crown radius and driver slot depth), to standardize the minor diameter, and to introduce ti-6al-4v alloy bone screws.