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When used as a pedicle screw fixation system in the non-cervical posterior spine (TI-SI) in skeletally mature patients, the VICEROY Spine 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 the thoracic, lumbar and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, and/or lordosis, (7) turnor, (8) failed previous fusion (i.e. pseudarthrosis).

The VICEROY Spine System consists of four or more pedicle screws and two VICEROY solid rods in a symmetric, bilateral arrangement. The pedicle screws are placed axially in the pedicles with two screws in the cephalad position and two screws in the caudad position. The VICEROY rods are secured in the heads of the pedicle screws so that fixed stabilization is provided between the cephalad and caudad vertebrae. Cross-links can be used if additional stabilization is necessary. The VICEROY Spine System is fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to the ASTM F136, Standard Specifications for Wrought Titanium-6Aluminum-4VanadiumELI (Extra Low Interstitial) Alloy or Surgical Implant Applications.