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The Blustone Synergy Diamond SA Cervical System 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 degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Blustone Synergy Diamond SA Cervical System may be used with additional supplemental fixation.

The BluStone Synergy Diamond Stand Alone (SA) Cervical System consists of the Diamond cervical interbody plate and screws to be used in conjunction with the Blustone Synergy Interbody Fusion SLATE cervical interbody fusion devices to form the Diamond Stand Alone Cervical System. The Diamond Stand Alone cervical system is designed to be used with allograft and/or autograft. Use of the Diamond SA Cervical System is intended to expedite the Anterior Cervical Device instrumentation procedure, while minimizing tissue disruption through a minimally invasive approach. The Diamond plate includes anterior nail spikes to resist rotation and two holes for insertion of the included bone screws as well as an integrated locking plate to resist bone screw backout. The Diamond cervical interbody plate and screws are manufactured from titanium alloy. Previously cleared SLATE cervical cages to be used with the Diamond plate and screws are manufactured from PEEK and include tantalum markers. All implant components are available in various sizes to accommodate varying patient anatomy.

The Blustone Synergy cervical (Slate Lavaflow) implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of carcellous 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. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. 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 lumbar (Lavaflow) implants are intervertebral body fusion devices indicated for use with autograff and/or allogenic bone graft comprised of cancellous 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 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 scolosis. The Blustone Synergy lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The Blustone Synergy Interbody Fusion System is composed of cervical and lumbar interbody fusion devices. The BluStone Synergy Slate Lavaflow System is a Titanium Plasma Coated cervical interbody fusion system comprised of parallel and 6° lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach. The Blustone Synergy Lumbar Interbody Lavaflow System is a Titanium Plasma Coated lumbar interbody fusion system comprised of various device configurations based on surgical approach and patient anatomy, and may be implanted via one of the following approaches: 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 transforaminal (TLIF) approach; or as a single device via a lateral (LLIF) approach. All Blustone Synergy Interbody Fusion 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. This Traditional 510(k) submission seeks to expand the sizes offered for the MAGMA LLIF cages as well as add commercially pure (CP) titanium plasma coating per ASTM F1580 to the subject new MAGMA cages as well as all previously cleared cervical and lumber interbody fusion devices. Plasma-coated implant options will be denoted as the LAVAFLOW subfamily. Finally, this submission seeks to offer all implants as sterile devices via sterilization by ethylene oxide (EO) in addition to the previously cleared non-sterile, non-coated options.