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The New Era Orthopaedics Polyscrew Pedicle Screw 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion. The New Era Orthopaedics Polyscrew Pedicle Screw System is also intended for noncervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The New Era Orthopaedics™ (NEO) Polyscrew Pedicle Screw System is designed to provide mechanical support while biologic fusion takes place. It has been developed with the objective of providing the surgeon with an adaptable fixation system in order to carry out dorsal stabilization of the spine simply, quickly and effectively. The New Era Orthopaedics™ (NEO) Polyscrew Pedicle Screw System is designed to provide mechanical support while biologic fusion takes place. Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to more closely match the patient's anatomy.

The NEO Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, undergoing surgery for total knee replacement due to: - . Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis. - . Failed osteotomies, failed partial knee replacement, or failed total knee replacement whose age, weight and activity level are compatible with an adequate long-term result. - Post-traumatic loss of joint configuration, particularly when there is . patellofemoral erosion, dysfunction or prior patellectomy. - Moderate valgus, varus, or flexion deformities. . The cruciate retaining (CR) femur with CR tibial insert is for use when the posterior cruciate ligament (PCL) is intact. The CR femur with UC tibial inserts is for use when the PCL is sacrificed. The posteriorly stabilized (PS) femur with PS tibial insert is for use when the PCL is sacrificed. The NEO Total Knee System components are indicated for use only with cement and are single use devices.

The NEO Total Knee System includes: - Cruciate retaining (CR) Femoral Components and Posteriorly stabilized (PS) Femoral . Components in right and left configurations in sizes 1 to 10, manufactured from Cast CoCr. - Tibial Trays manufactured from titanium alloy in sizes 1 – 10. - . Tibial Inserts in cruciate retaining (CR), ultracongruent (UC), and posteriorly stabilized (PS) designs, manufactured from standard ultrahigh molecular weight polyethylene, in sizes A to E and in thicknesses 6 to 21 mm (total thickness with tibial tray is 9 to 24 mm). - Patellar Components in diameters of 26 to 41 mm and in thicknesses of 8, 9 or 10 mm, manufactured from standard ultrahigh molecular weight polyethylene. The NEO Total Knee System is designed with the potential to have an active clinical flexion of 150°.