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The Kestrel Posterior Cervical Fixation System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3). The system is intended for posterior, cervical, non-pedicle fixation, or for posterior, noncervical pedicle fixation for the following indications: - Degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - Spondylolisthesis - Trauma (i.e fracture or dislocation) - Spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and /or lordosis) - Tumor - Pseudoarthrosis - Failed previous fusion Occipital bone screws are limited to occipital fixation only. Pedicle bone screws are limited to placement in the upper thoracic spine (TI, T3) when anchoring the OCT construct only. Pedicle screws are not intended to be placed in the cervical spine. Hooks and wires (not pedicle screws) are used to achieve cervical fusion for the occipital/cervical loop

The proposed SPINE360 Kestrel system consists of screws, locking caps, rods, cross links, hooks, and instruments.

The Spine360 Stingray Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Spine 360 Cervical Interbody Fusion System implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to T1 disc levels using autograft bone. The Spine 360 Cervical Interbody Fusion System implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Stingray Cervical Cage was developed as an intercorporal implant for anterior cervical spondylosis. Stingray is a system of wedge-shaped implants and instruments designed for anterior cervical interbody fusion (ACF). In the lateral view, the implant has a 3.5° lordotic form. The Stingray Cervical Cage has a flat top and bottom. Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) and tantalum according to ASTM F560.

The Spine 360 Talon Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis).

The Talon Spinal Fixation System was cleared for use via K071824, and is comprised of polyaxial screws, locking plugs, spinal rods and rod to rod connectors. The Talon System can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Spine 360 proposes to add new smaller diameter (4.5mm) screws in various lengths, cannulated screws in various diameters and lengths, pedicle screw spacers as well as the minimally invasive surgical technique for use with the Spine 360 Talon Spinal System. The new components are based upon the same fundamental scientific technology and do not alter the indications for use as compared to the existing system.