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The Athena Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. The system is intended for posterior, pedicle fixation as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Athena Pedicle Screw System is comprised of polyaxial pedicle screws in various diameters and lengths, spinal rods in various lengths, cross-connectors and set screws. The Athena Pedicle Screw System can be used for single or multiple level fixations. All implant components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

The Helena System is indicated for intervertebral body fusion of the lumbar spine, from L2 to Sl, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Helena System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of: Lumbar interbody fusion device(s), which may be implanted bi-laterally via a posterior (PLIF) approach; as a single device via a transforaminal (TLIF) approach - as a single device via an anterior (ALIF) approach; or The Helena System implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The Helena System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.