Device Dossier

CP-ESP® disc prosthesis - Cervical total disc replacement prosthesis

Device Dossier for CP-ESP® disc prosthesis - Cervical total disc replacement prosthesis (Cervical total disc replacement prosthesis, Class III, sponsor…

Intended purpose

The devices are intended for cervical spine implantation between C3 and C7 during cervical disc arthroplasty.

Functional description

The devices are intended for cervical spine implantation between C3 and C7 during cervical disc arthroplasty. The CP-ESP® cervical disc prosthesis is composed of two titanium alloy plates, separated by a deformable portion that is intended to allow the disc to move. The prosthesis has spikes on the external surface and an hydroxyapatite (HA) coating over a layer of pure titanium (T40). The deformable portion consists of an elastomeric cushion made from polycarbonate urethane.

TGA Public Summary