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The Kepler I Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Kepler I Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, lordosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions. This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

The Kepler I Cervical Plate System is a system that includes titanium alloy (per ISO 5832-3) plates and screws that are intended to stabilize the spine during the fusion process. The plates and screws are available if various sizes to accommodate patients' anatomy. The plates are contoured to follow the curves of the cervical spine.

The Hubble I System is indicated for use for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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; pseudarthrosis; and failed previous fusion.

The Orbbo Hubble I System is an implant device made from a titanium alloy Ti 6Al-4V ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. The titanium alloy implants are provided sterile. The cobalt-chrome implants are provided non-sterile. It is to be implanted from the posterior approach. The screws are available as monobloc reduction (traction) screws and polyaxial and polyaxial reduction (traction) screws in diameters from 4.0 - 8.0 mm and in lengths from 25 - 55 mm and polyaxial illac screws of 7 and 8mm diameters with lengths from 55mm to 110mm. Rods are available in 5.5mm diameter in lengths from 40 - 500 mm. Hooks are available in various sizes to attach to the thoracic and lumbar spine. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided non-sterile.