Search Results

When used as a cervical intervertebral body fusion device, the Integrity Spine Core System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain 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. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Integrity Spine Core System is a cervical interbody fusion system comprised of 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 Integrity Spine Core System implant components are made of polyether ether ketone (PEEK, Zeniva ZA-500) that conforms to ASTM F2026. The devices are plasma spray coated with titanium that conforms to ASTM F1580. Additionally, the devices contain tantalum markers that conform to ASTM F560 to assist the surgeon with proper placement of the device. The Integrity Spine Core System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel that conforms to ASTM F899.

The Integrity Spine Lumbar Interbody Fusion 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 or retrolisthesis 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. These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Integrity Spine Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Integrity Spine lumbar interbody fusion device(s) may be implanted: - bi-laterally in pairs via a posterior (PLIF) approach; - as a single device via an oblique (OLIF) approach: - as a single device via a transforaminal (TLIF) approach; or - as as a single device via an anterior or anterolateral (ALIF) approach. 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. The implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

When used as a cervical intervertebral body fusion device, the Integrity Spine Core System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain 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. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

The Integrity Spine Core System is a cervical intervertebral body fusion system comprised of parallel and 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 Integrity Spine Core System implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The Integrity Spine Core System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.