DevicePMAs@therightstef:P000023_S000 JSONTXT 11 Projects

Approval for the tmj fossa-eminence/condylar prosthesis system. The device is indicated for reconstruction of the temporomandibular joint. Patients should be considered if they have one or more of the following conditions: 1) inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment 2) recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment 3) failed tissue graft 4) failed alloplastic joint reconstruction 5) loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion.