"The SASCA (Southern Anterior Screw Fixated Cage) Genesis devices include the SASCA-G and SASCA-2G, Ti-6Al-4V ELI (ASTM F136) stand-alone lumbar interbody fusion cages. These are wedge-shaped, 3D-printed, porous cages intended for use in anterior lumbar interbody fusion (ALIF) procedures. SASCA-G and SASCA-2G are intended to immobilise and stabilise the spinal column, restore and maintain spinal curvature and facilitate fusion in the lumbar spine. The devices are stand-alone devices and must be used with three Ti-6AL-4V-ELI (ASTMF136) screws, as provided, which are placed into the PEEK (ASTM F2026) placement rings. Supplementary spinal fixation is not required. The devices have a central cavity intended to be filled with autograft or allogenic bone graft.
The devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to S1. DDD is defined as backpain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The devices may also be used in patients with pseudarthrosis /non-union from previous unsuccessful fusion surgery. Patients should have undergone at least six months of non-operative treatment."