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IdentiTi II ALIF Standalone Interbody System

The IdentiTi II ALIF Standalone Interbody System is indicated for spinal fusion procedures from L2 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. When used with screws or blades, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

Additionally, the IdentiTi II ALIF Standalone Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis (>Grade 1) and spinal stenosis at one or two adjacent levels, the IdentiTi II ALIF Standalone Interbody System must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. The IdentiTi II ALIF Standalone Interbody System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

When used with three (3) screws, interbody implants of <=20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels without the need for supplemental fixation.

When used with three (3) blades, a combination of three (3) screws and blades, or less than three (3) screws and/or blades, interbody implants must always be used with supplemental fixation.

When used with or without screws and/or blades, interbody implants of >20° must always be used with supplemental fixation.

Transend ALIF Standalone Interbody System

The Transcend ALIF Standalone Interbody System is indicated for spinal fusion procedures from L2 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. When used with screws or blades, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

Additionally, the Transcend ALIF Standalone Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis (>Grade 1) and spinal stenosis at one or two adjacent levels, the Transcend ALIF Standalone Interbody System must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. The Transcend ALIF Standalone Interbody System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

When used with three (3) screws, interbody implants of <=20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels without the need for supplemental fixation.

When used with three (3) blades, a combination of three (3) screws and blades, or less than three (3) screws and/or blades, interbody implants must always be used with supplemental fixation.

When used with or without screws and/or blades, interbody implants of >20° must always be used with supplemental fixation.

The IdentiTi II and Transcend ALIF Standalone Interbody Systems are integrated intervertebral body fusion systems with integrated screw and/or blade fixation for use in anterior and anterolateral procedures. The subject IdentiTi II interbody spacers are additively manufactured via full-melt powder bed fusion (laser melting) from titanium alloy powder (Ti-6Al-4V ELI) conforming to ASTM F3001. The subject Transcend interbody spacers are an assembly of additively manufactured titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001, PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, and titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136. The IdentiTi II and Transcend ALIF Standalone interbody spacers are offered in various widths, heights, lengths, lordotic, and anti-migration options to accommodate individual patient anatomy and surgeon preference. The IdentiTi II and Transcend interbody implants are not patient matched. All interbody implants feature an internal graft aperture for placement of graft material to promote fusion through the cage. The interbody spacers accept up to three integrated bone screws and/or blades. The screws and blades are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 in varying lengths and diameters, and they mitigate the risk of expulsion of the interbody spacers. To mitigate risk of expulsion, the interbody endplates consist of roughed anti-migration surfaces and teeth. Additionally, the additively manufactured portions of the IdentiTi II (full spacer) and Transcend (anterior faceplate) implants are offered with a microporous/macroporous lattice structure that spans the entirety of the implant and extends to the superior and inferior surfaces of the device for biological fixation. The interbody implants are provided terminally sterile via gamma irradiation while the bone screws, blades, and reusable instruments are provided non-sterile to be steam sterilized by the end user.

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