Medical grade Titanium with full identification, traceability and manufactured to strict ISO13485 and FDA standards.
The Titamed Spinal System is intended for use in: anterior, anterolateral, or posterior non-cervical pedicle and non-pedicle fixation for spinal conditions with significant mechanical instability or deformity requiring fusion of the thoracic, lumbar or sacral spine secondary to the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Titamed Spinal System appears in The SA Medical Journal publication “The Radiological Outcome Of Lumbar Spinal Fusion Using A South African Developed Dynamic Spinal Fixation System” (click to download) comparing the efficacy, fusion rate and breakage rates of 18 international spinal implant systems. The Titamed Spinal System was found to have one of the highest fusion rates (93%) and the significantly lowest breakage rate (0.3% for screws and 0% for rods).