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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
TMJ
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