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The Theken VU VBR SYSTEM is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The Theken VU VBR SYSTEM is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absences of fusion for a prolonged period. Bone graft material is recommended to be packed into the interior openings of the device prior to implantation. The Theken VU VBR SYSTEM is intended to be used with supplemental internal spinal fixation systems, such as the Theken BodyForm Thoracolumbar Fixation System (K983622), Approved 12/98) or the Theken Coral Pedicle Screw System (K041592, Approved 9/04).

The Theken VU VBR SYSTEM is comprised of rounded rectangular and rectangular cages with fenestrations and radii on all sides and toothed spikes which are used in combination with spacer components. The cages and spacer can be locked together into a variety of geometric configurations to fit each individual patient's pathology. The toothed spikes of the rounded rectangular and rectangular cages engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. A single construct is sufficient to be used at all spinal levels and pathologies.

The CPOD/LPOD is indicated for use in the thoracolumbar spine (i.c. T1 to L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (e.g. fracture). The CPOD/LPOD is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. middle alle posterior upmar over and to be packed into the interior openings of the device prior to implantation. The CPOD/LPOD is intended to be used with supplemental, internal spinal fixation The Cr OD/El OD is intended to or arm Thoracolumbar Fixation System (K983622) or the DePuy Acromed ISOLA System (K980485).

The Theken CPOD / LPOD VBR is comprised of Titanium rounded rectangular and rectangular frames with fenestrations and radii on all sides and toothed spikes which are used in combination with Titanium spacer components. The frames and spacer can be locked together into a variety of geometric configurations to fit each individual patient's pathology. The toothed spikes of the rounded rectangular and rectangular frames engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. A single construct is sufficient to be used at all spinal levels and pathologies. The Theken CPOD / LPOD VBR System is designed to be constructed using two cage components in conjunction with an appropriate single spacer component. This combination of components creates an implantable construct. The use of a single cage as an implant has not been tested or approved.

The Theken Large Cement Restrictor is designed to occlude the medullary canal before the introduction of acrylic cement during surgeries such as total hip arthroplasty, as well as prevent cement from flowing down the diaphysis thereby facilitating cement pressurization. The Theken Large Cement Restrictor is NOT intended for any spinal indications.

The Theken Large Cement Restrictor is titanium, hollow, rectangular frame with The Thelions and radii on all sides and toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.

The Theken Small Cement Restrictor is intended for use as a cement restrictor in orthopaedic surgeries such as those involving the tibial plateau in total knee replacement. The Theken Small Cement Restrictor is NOT intended for any spinal indications.

The Theken Small Cement Restrictor is a hollow, titanium, and rounded rectangular frame with fenestrations on all sides and toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.

The Tether™ ACFS is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, scollosis); pocudour.hrools; provised as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), spondylolisthesis, and spinal stenosis. The Tether™ ACFS is indicated for temporary stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.

The Tether ACFS is a titanium alloy anterior cervical plate fixation system. The Tether AOTO 13 a titaniam anoy and come in a variety of lengths. Screws Prates are pre-contoured in two planos, and two different styles; fixed and variable in two diametors, cororal rengine are used to build a rigid fixation angle and variable angle screws are used to build a non-rigid construct. Hybrid constructs are possible by combining fixed and variable angle screws. A locking constructs are possible by comemages the plate hole upon entry into the plate and provides a mechanical lock against screw back-out.

The BodyForm Thoraco-Lumbar Fixation System is intended for treatment of anterior thoraco-lumbar spinal instability caused by: 1. Trauma. 2. Tumor. 3. Degenerative Disc Disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. 4. Anterior fusion following multiple failed posterior fusion operations, including pseudoarthrosis. The instrumentation is designed for levels of fixation from T10 to L4.

The BodyForm™ Thoraco-Lumbar Fixation System is a construct which consists of one plate, contoured to match the lateral profile of the thoraco-lumbar vertebral bodies, four Morse taper headed screws, and two locking set screws. Plates are designed specifically to particular graft heights, with anatomic limitations in mind.