INDICATIONS FOR USE

The TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) Reconstruction Prosthesis 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

For more detailed information, please view the FDA's web site at www.fda.gov/cdrh/pdf/p980052.html

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