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When used as a lumbar intervertebral body fusion device, the Republic Spine Restore Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, 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 1 spondylolisthesis 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 Republic Spine Restore Intervertebral Body Fixation System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Republic Spine lumbar intervertebral body fusion device, which may be implanted as a single device via an anterior, posterior, transforaminal or lateral approach. The Republic Spine Restore Intervertebral Body Fusion System implant components are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 or polyether ether ketone (Evonik Vestakeep® i4R) that conforms to ASTM F2026 with tantalum markers (ASTM F560) to assist the surgeon with the proper placement of the device.