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The Space Vision® PLIF (Posterior Lumbar Interbody Fusion® TLIF (Transforaminal Lumbar Interbody Fusion) and Space Vision® OLIF (Oblique Lumbar Interbody Fusion) systems are intervertebral body fusion devices indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two continuous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least 6 months of non-operative treatment prior to treatment with Space Vision® PLIF, SpaceVision® TLIF systems. These devices are to be filled with autogenous bone graft material. These devices can be implanted via posterior or transforaminal approaches. SpaceVision® PLIF, SpaceVision® TLIF or SpaceVision® OLIF systems must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine.

The SpaceVision® PLIF system (Posterior Lumbar Interbody Fusion), the SpaceVision® OLIF system (Oblique Lumbar Interbody Fusion) and the SpaceVision® TLIF system (Transforaminal Lumbar Interbody Fusion) are intended as an internal spacer between the vertebral bodies of the lumbar (L2-S1) spine to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain. The design of the cages is adapted to the vertebral anatomy. SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF systems consist of cages differentiated by their approach, with varying dimensions and ancillary products for placement of the cages. The systems are supplied sterile or non-sterile. The SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF cages are made from PEEK Optima (Invibio, Inc.) ASTM F2026 and ASTM F560 Tantalum wire. X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment. SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF implants are supplied with their specific instrumentation and trial spacers.

When used for anterior screw fixation or as a posterior, non-pedicle system of the non-cervical spine, the U.L.I.S.™ and LUMIS™ systems are indicated for: • Degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) • Spondylolisthesis • Fracture • Spinal stenosis • Tumors • Failed previous fusion (pseudoarthrosis) The U.L.I.S.™ and LUMIS™ systems are pedicle screw systems indicated for skeletally mature patients who: • have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; • receive fusions using autogenous bone graft only; • have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and • have the device removed after the development of a solid fusion. In addition, the U.L.I.S.™ and LUMIS™ systems are pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T10-S1): • Degenerative spondylolisthesis with objective evidence of neurologic impairment • Fracture • Spinal tumor • Failed previous fusion (pseudoarthrosis)

The SpineVision® Universal Lumbar Intuitive System (U.L.I.S.™ System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) are composed of cannulated (LUMIS™) and non-cannulated (U.L.I.S.™) pedicle screws and fixation rods. Their components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient and are supplied non-sterile. The purpose of this submission is to include new devices: the U.L.I.S.™ Multi-Axial Reduction Screws, additional instruments to the U.L.I.S.™ System; additional lengths for the LUMIS™ Spinal Rods; and the use of LUMIS™ Spinal Rods with U.L.I.S.™ System.