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The Fortilink-A Ti is indicated for anterior interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment with an interbody fusion device. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior FDA cleared supplemental fixation. The Fortilink-C Ti is intended for spinal fusion procedures at one or more levels (C2-T1) in skeletally mature patients with cervical disc disease (defined as discogenic back pain with degeneration of the disc and/or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radios), instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. Implants are to be packed with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. This device is intended to be used with an FDA-cleared supplemental fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment. The Fortilink-L Ti is indicated for lateral interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment with an interbody fusion device. The Fortilink-SA Ti is indicated for stand-alone anterior lumbar interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft to facilitate fusion and is implanted via an anterior approach. Implants must be used with three of the provided bone screws. This system is to be used in patients who have had six months of non-operative treatment. The Fortilink-SA Ti with lordotic angles greater than or equal to 20 degrees requires the use of FDA cleared supplemental fixation in addition to the screws intrinsic to the interbody spacer. The Fortilink-SC Ti is intended for stand-alone anterior cervical interbody fusion procedures at one or two levels (C2-T1) in skeletally mature patients with cervical disc disease (defined as discogenic back pain with degeneration of the disc and/ or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radiographic studies), instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. The system is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and is implanted via an anterior approach. Implants must be used with two of the provided bone screws. This system is to be used in patients who have had six weeks of non-operative treatment. The Fortilink-TC Ti is indicated for transforaminal interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment with an interbody fusion device. The Fortilink-TS Ti is indicated for transforaminal and posterior interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment with an interbody fusion device.

The purpose of this Traditional 510(k) is to seek marketing clearance for the Fortilink Cages with TiPlus Technology. The Fortilink Cages with TiPlus Technology are used to restore intervertebral height and to facilitate intervertebral body fusion in the spine using various surgical approaches with autogenous bone graft and/or allogenic bone graft materials. The Fortilink Cages with TiPlus Technology are intended to be used from on various spinal sections, depending on the cage. These devices can used with and without supplemental fixation (see Section 11). The Fortilink Cages with TiPlus Technology are made from Ti-6Al-4V ELI (ASTM F3001) by an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows the cage to be packed with autogenous and/or allogenic bone graft.