Indications / Contraindications For Use

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