INDICATIONS

The BalancedBack Total Joint Replacement is indicated for disorders requiring nerve decompression, restabilization, and maintenance of or improvement in sagittal balance. The subject has a primary diagnosis of lumbar degeneration (e.g. HNP, central disc herniation, annular tear) with or without facet degeneration with or without stenosis of the lumbar spine from L1 to S1 confirmed by subject history (e.g. leg and/or back pain or symptoms in the sciatic nerve distribution) and radiographic studies (e.g. MRI and plain radiographs) with no more than a Grade I Spondylolisthesis (< 3mm).