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The Atalia Titanium Surgical Mesh is indicated for use in the thoraco-lumbar spine (T1-LS), in cases where one vertebral body has been structurally compromised either by tumor or trauma. The objective is the restoration of anterior column support through introduction of a corpectomy construct in tandem with bone graft to ultimately realize spinal fusion. The Atalia Titanium Surgical Mesh is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and/or lumbar spine.

The Atalia Titanium Surgical Mesh is a round-patterned, surgical mesh device. The body is manufactured from TI-6AL-4V ELI Alloy conforming to ASTM F 136. Because of the construction, the angle and the length of the mesh can be reduced incrementally to adjust it to individually anstomical conditions. The Atalia Surgical Mesh System is sold non-sterile.

The LTD Polyaxial Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the LTD Polyaxial Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spiral tumor, and/or (5) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the LTD Polyaxial Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass. When used as a posterior, non-cervical, non-pedicle screw fixation system, the LTD Polyaxial Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by bark nin of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) turnor resection, and/or (7) failed previous fusion.

The LTD Polyaxial Fixation System consists of a variety of shapes and sizes of rods, screws and connecting components, sold with or without the surgical instrument tray. These components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The LTD Polyaxial Fixation System implant components are fabricated from medical grade titanium or titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2