Indications
The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibular joint. It is indicated for patients with one or more of the following conditions:
- Inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment
- Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment
- Failed tissue graft
- Failed alloplastic joint reconstruction
- Loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion
Contraindications
The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System should not be used for patients with one or more of the following conditions:
- Active or suspected infections in or about the implantation site
- Uncontrollable masticatory muscle hyperfunction (clenching or grinding) which may lead to overload and loosening of screws
- Known allergy to any of the component materials