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The IN:C2 Spinal Fixation System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. IN:C2 is a stand-alone device intended to be used with an anterior cover plate and a minimum two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral body. The implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.

SpineSmith Partners LLP developed the IN:C2 Spinal Fixation System to be used during spinal fusion. IN:C2 serves to stabilize the spine while bony fusion develops. The IN:C2 System consists of a 'U' shaped PEEK block in multiple footprint configurations, heights and lordosis angles. The PEEK implants contain a titanium marker intended to verify position radiologically. The IN:C2 is a stand-alone system, intended for use with its cover plate assembly and two titanium bone screws provided. The IN:C2 implant is intended to be implanted via an open anterior approach. The anterior cover plate assembly attaches to the anterior most portion of the device. and includes housing features for placement of two bone screws angled cephalad and caudal. The cover plate assembly and integrated screws are supplemental fixation.

The VisuALIF 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 I spondylolisthesis. 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 autograft to facilitate fusion. The VisuALIF is a stand-alone device intended to be used with an anterior cover plate and a minimum of two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral body. Should the physician choose to use fewer than the two screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided.

The VisuALIF Challenging Access System an extension to the VisuALIF System and both are part of the Cynch Spinal System. It is available in various sizes to accommodate individual patient anatomy. The VisuALIF Challenging Access implant is a lumbar intervertebral body fusion device that is intended to be implanted singularly via an open anterior approach. VisuALIF Challenging Access is intended to be used with the two (2) or more bone screws provided with the accompanying anterior cover plate assembly. The Cynch System implants are manufactured from PEEK Optima LT1 and contain three (3) radiopaque tantalum markers to assist the surgeon with proper placement of the device.

The Cynch System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, 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 I spondylolisthesis. 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 Cynch System Visualif is a stand-alone device intended to be used with the two bone screws provided and the accompanying anterior cover plate. Should the physician choose to use fewer than the two screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided.

The Visualif System is part of the Cynch Spinal System and is available in various sizes to accommodate individual patient anatomy. The Visualif implant is a lumbar intervertebral body fusion device that is intended to be implanted singularly via an open anterior approach. Visualif is a stand-alone device intended to be used with two (2) bone screws provided and the accompanying anterior cover plate assembly. NOTE: The cover plate assembly and screws are part of the implant construct. Addition of an ALIF version to the existing Cynch System is intended to provide surgeons with additional surgical approach options. There are no changes with respect to indications or intended use as compared to the Cynch Spinal System cleared previously via K090376. The Cynch System implants are manufactured from PEEK Optima LT1 and contain three (3) radiopaque tantalum markers to assist the surgeon with proper placement of the device. The subject device (Visualif - ALIF device) has similar technological characteristics as the predicate devices identified above (SpineSmith's Cynch System per K090376).

The Cynch System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, 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 I spondylolisthesis. 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 SpineSmith Cynch System is offered in two (2) configurations of various sizes. The configurations are designed based on indicated spinal implant level and surgical approach. The system consists of the Cynch TLIF device for transforaminal lumbar approach and the Cynch PLIF/T-PLIF device, which may be implanted via a posterior lumbar bi-lateral approach or transverse lumbar approach. The Cynch System implants are manufactured from PEEK Optima LT1 and contain three (3) radiopaque tantalum markers to assist the surgeon with proper placement of the device. The Cynch System implants are hollow to allow for the placement of autograft bone, and have large anterior graft windows to facilitate fusion. There are teeth on the superior and inferior surface of the implants to provide increased stability and inhibit movement of the implant. The implants have horizontal grooves to locate the implant holder superior/inferior and rotationally. Additionally, a cross-bar is provided to minimize buckling during insertion.

The Cynch System is indicated intervertebral body fusion of the lumbar spine, from L2 to SI, 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 I spondylolisthesis. 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.

Cynch is curved to allow for medial-lateral placement of the device, and is available in two footprints (25mm and 30mm) with a 5° lordosis in various heights. Cynch is hollow to allow for the placement of autograft bone, and has large anterior graft windows to facilitate fusion. There are teeth on the superior and inferior surface of the device to provide increased stability and inhibit movement of the implant.

The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of the following indications: - Degenerative disc disease [DDD] defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies - Spondylolisthesis - Spinal Stenosis - Tumors - . Trauma (i.e. fracture)

The Cequence anterior cervical plates are preassembled and are offered in both a constrained and semi-constrained configuration. Cequence consists of four (4) primary components: 1) anterior plate, 2) self-tapping bone screws, 3) locking screws and 4) locking plate.

The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine at one level between C2-C7 for the following indications: - . Degenerative disc disease [DDD] - defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - . Spondylolisthesis - Spinal Stenosis . - Tumors . - Trauma (i.e. fracture) .

The Cequence anterior cervical plates are preassembled and are offered in both a constrained and semi-constrained configuration. Cequence consists of four (4) primary components: 1) anterior plate, 2) self-tapping bone screws, 3) locking screws and 4) locking plate.

The Cimplicity System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The Cimplicity device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone. When used as an intervertebral body fusion device, the Cimplicity System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-TI disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Cimplicity implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with a Cimplicity interbody fusion device.

Cimplicity is a rectangular shaped implant, which is available in a parallel or lordotic configuration of various heights. Cimplicity is hollow to allow for the placement of allograft or autograft bone. There vare teeth on the superior and inferior surface of the device to provide increased stability and inhibit movement of the implant.

The Cimplicity Spinal Fixation System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Cimplicity implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of nonoperative treatment prior to treatment with an intervertebral cage.

The Cimplicity system is a rectangular interbody fusion device. The device is hollow and may be filled with graft material. Various sizes are provided to accommodate patient anatomy. Cimplicity is made from PEEK and has tantalum beads used for radiographic visualization.