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Blustone Synergy lumbar implants (Basalt, Magma, Obsidian): The Blustone Synergy lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy. Additionally, the Blustone Synergy lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Blustone Sysergy lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. Blustone Synergy cervical implants (Slate): The Blustone Synergy cervical (Slate) implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Blustone Synergy cervical implants are also to be used with supplemental fixation.

The Blustone Synergy Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of: - Blustone Synergy cervical interbody fusion device(s), which may be implanted as a single 1) device via an anterior approach. - 2) Blustone Synegy lumbar interbody fusion device(s), which may be implanted - bi-laterally in pairs via a posterior (PLIF) approach; - as a single device via a transverse (T-PLIF) approach; - as a single device via a lateral (LLIF) approach; - as a single device via a transforaminal (TLIF) approach The Blustone Synergy System implant components are made of polyether ether ketone (Zeniva ZA-500 PEEK) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.