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The XIPHOS™ ZFUZE™ Interbody Fusion 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 is designed for use with supplemental fixation and with autograft to facilitate fusion.

The XIPHOS™ ZFUZE™ Interbody Fusion System is a single use sterile- packed permanent implant identical to that of the construct in the cleared XIPHOS™ Interbody Fusion system (K100042). The DiFUSION Technologies XIPHOS™ ZFUZE™ Interbody Fusion System is comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options. The XIPHOS™ ZFUZE™ Interbody Fusion System will be offered in two (2) configurations of various sizes like its predicate XIPHOS™. The configurations are designed based on indicated spinal implant level and surgical approach, and consist of: 1) XIPHOS™ ZFUZE™ PLIF, posterior lumbar approach and 2) XIPHOSTM ZFUZE™ TLIF, transforaminal lumbar approach. XIPHOS™ ZFUZE™ Interbody Fusion System implants consist of bullet shaped (PLIF) and banana shaped (TLIF) blocks in a parallel configuration of various heights. Large bone graft windows are located through the body of the device to allow for placement of bone graft to facilitate fusion. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants. Additionally, the device contains four (4) radiolucent tantalum markers in the PLIF configuration and five (5) radiolucent tantalum markers in TLIF configuration to assist the surgeon with proper placement of the device. The PLIF device may be implanted singularly or in pairs via a posterior approach while The TLIF device may be implanted singularly via a transforaminal approach. The XIPHOS™ ZFUZE™ Interbody Fusion System is made of Ketaspire PEEK (KT1211FP) and Type 4A Zeolite. In addition tantalum beads are embedded in the spacers to allow radiographic visualization. These permanent implants are available for prescription use only.

When used as an intervertebral body fusion device, the DiFUSION Technologies XIPHOS Interbody Fusion 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 spondvlolisthesis. 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. When used as a vertebral body replacement device, the DiFUSION Technologies XIPHOS 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 XIPHOS System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental 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. The DiFUSION Technologies XIPHOS System is intended to be used with autograft or allograft bone.

The XIPHOSTM ALIF is a lumbar PEEK interbody fusion device. These implants can be described as an oval structural column having a central strut. The superior and inferior surfaces are open with parallel serrations. The implants are available in an assortment of height, depth, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.

Intervertebral Body Fusion Device: The DiFUSION Technologies XIPHOS Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to Sl, 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. Vertebral Body Replacement Device: The DiFUSION Technologies XIPHOS System of implants 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 XIPHOS System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental 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.

The DiFUSION Technologies XIPHOS Interbody Fusion System is comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options. The XIPHOS System will be offered in two (2) configurations of various sizes. The configurations are designed based on indicated spinal implant level and surgical approach, and consist of: 1) XIPHOS PLIF, posterior lumbar approach and 2) XIPHOS TLIF, transforaminal lumbar approach. The XIPHOS System implants are manufactured from PEEK Zeniva ZA-500 (ASTM F-2026) with Tantalum alloy position markers (ASTM F-560).