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The CarboClear Cervical Cage System is indicated for intervertebral body fusion procedures of the cervical spine in skeletally mature patients with degenerative disc disease (DDD) at levels C2 – T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The implants are to be implanted via an open, anterior approach and packed with autograft comprised of cancellous and/or corticocancellous bone graft. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine. Patients should receive at least six (6) weeks of non-operative treatment with the CarboClear Cervical Cage System. The CarboClear Cervical Vertebral Body Replacement (VBR) System Spacers are vertebral body replacement devices intended for use in the cervical spine (C2 - T1). The CarboClear Cervical VBR devices are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. The devices are intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the cervical spine (i.e., posterior screw and rod systems, and anterior plate systems). When used at more than two levels, supplemental fixation should include posterior fixation. The use of allograft or autograft with the CarboClear Cervical VBR device is optional.

1. CarboClear Cervical Cage System is composed of implants of various sizes, and of instruments. The CarboClear Cervical Cage is made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates. 2. The CarboClear Cervical VBR System is composed of implants (spacers) in various sizes, and of instruments. The CarboClear Cervical VBR spacers are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates.

The CarboClear® Lumbar Cage System is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD), at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The patients may also have up to Grade I spondylolisthesis at the involved levels. CarboClear® Lumbar Cage System is intended for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and with supplemental fixation cleared for use in the lumbosacral spine. Patients should have at least six months of non-operative treatment prior to surgery.

CarboClear® Lumbar Cage System is composed of implants of various sizes and lordotic angles, and instruments. The CarboClear® Lumbar Cage is made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates. It is implanted in the intervertebral disc space with bone graft and is designed to maintain disc height and to facilitate vertebral fusion. The CarboClear® Lumbar Cage System should be used with a supplemental fixation system.