Diamond Stand Alone SA Cervical System
The Blustone Synergy Diamond SA Cervical System are stand-alone integrated 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 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 plate assembly and cervical plate screws to be used in conjunction with the Blustone Synergy Interbody Fusion System SLATE(or SLATE Lavaflow) 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 Blustone Synergy Diamond SA Cervical System is low profile to allow for placement in the anterior cervical spine with less disruption of the surrounding anatomy and easier insertion into the intervertebral body. 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 back-out.
The Cervical Plate Assembly is screwed tightly onto the matching SLATE(Lavaflow) System via the center Locking Nut and inserted into the intervertebral body. Two screws are inserted thru the Cervical Plate Assembly at approximately 35 degrees cephalad/caudal and 5 degrees medial, and the Rotating Locking Plate is locked. The cervical plate screws are available in a variety of diameters and lengths, 4.0mm and 4.25 x 12-18mm, increments of 2mm. The cervical plate assembly is available in both a 14mm width and a 17mm width, with heights ranging from 6-11mm in 1 mm increments. The SLATE(Lavaflow) System Interbody Fusion Device is available in 2 footprint geometries, 14x11mm or 17x13mm, both lordotic and parallel profiles, with heights ranging from 6-11mm in 1mm increments to match their corresponding Cervical Plate Assembly. The Diamond Cervical Plate Screws and Plate Assembly are made from Titanium Alloy, SLATE Interbody from Zeniva PEEK, and SLATE Lavaflow from Zeniva PEEK coated with CP Titanium. This comprises the Blustone Synergy Diamond Stand Alone (SA) Cervical System. The device may be implanted as a single device via an anterior approach with autograft or allograft for fusion of the cervical spine.
Do not use the Blustone Synergy Diamond SA Cervical System components with the components from any other system or manufacturer.
The Blustone Synergy Diamond SA Cervical System are stand-alone integrated 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 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 plate assembly and cervical plate screws to be used in conjunction with the Blustone Synergy Interbody Fusion System SLATE(or SLATE Lavaflow) 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 Blustone Synergy Diamond SA Cervical System is low profile to allow for placement in the anterior cervical spine with less disruption of the surrounding anatomy and easier insertion into the intervertebral body. 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 back-out.
The Cervical Plate Assembly is screwed tightly onto the matching SLATE(Lavaflow) System via the center Locking Nut and inserted into the intervertebral body. Two screws are inserted thru the Cervical Plate Assembly at approximately 35 degrees cephalad/caudal and 5 degrees medial, and the Rotating Locking Plate is locked. The cervical plate screws are available in a variety of diameters and lengths, 4.0mm and 4.25 x 12-18mm, increments of 2mm. The cervical plate assembly is available in both a 14mm width and a 17mm width, with heights ranging from 6-11mm in 1 mm increments. The SLATE(Lavaflow) System Interbody Fusion Device is available in 2 footprint geometries, 14x11mm or 17x13mm, both lordotic and parallel profiles, with heights ranging from 6-11mm in 1mm increments to match their corresponding Cervical Plate Assembly. The Diamond Cervical Plate Screws and Plate Assembly are made from Titanium Alloy, SLATE Interbody from Zeniva PEEK, and SLATE Lavaflow from Zeniva PEEK coated with CP Titanium. This comprises the Blustone Synergy Diamond Stand Alone (SA) Cervical System. The device may be implanted as a single device via an anterior approach with autograft or allograft for fusion of the cervical spine.
Do not use the Blustone Synergy Diamond SA Cervical System components with the components from any other system or manufacturer.