Device Dossier

Mobi-C Plug & Fit - Cervical total disc replacement prosthesis

Device Dossier for Mobi-C Plug & Fit - Cervical total disc replacement prosthesis (Cervical total disc replacement prosthesis, Class III, sponsor Equinox…

Intended purpose

The Mobi-C® Plug & Fit is a device for cervical intervertebral disc replacement in order to restore segmental motion and disc height. Indicated in skeletally mature patients for reconstruction of one or two degenerated disc(s): From C3 to C7 with intractable symptomatic cervical disc disease. With at least one of the following conditions: herniated nucleus pulposus and/or spondylosis.

Functional description

The prosthesis consists of a superior spinal plate, an inferior spinal plate and a mobile insert. The inner contact surface of the inferior plate is flat and contains two lateral stops. The function is based on the mobility of the core, which is controlled by the lateral stops on the inner surface of the inferior plate, and which ensures the rotation-translation coupling. Anchorage through lateral teeth ensures for the initial stability without any additional fixation.

TGA Public Summary