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The KHEIRON® Spinal Fixation System is intended to provide immobilization 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 disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion. When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the KHEIRON System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the KHEIRON Spinal Fixation System is intended to treat pediatic patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The KHEIRON® Spinal Fixation System is used in a variety of conditions that affect the thoracic and lumbar spine. In cases in which the posterior elements are fractured, the pedicle screw offers an excellent means of stabilizing a specific spinal segment. The KHEIRON Spinal Fixation System includes screws, anchoring, connecting components, hooks, iliac extensions, and crosslinks in a range of sizes and shapes that can be locked in various configurations, with each assembly being tailor-made to the patient's anatomical condition. The KHEIRON pedicle screws must be used with 5.5mm and 6.0mm rods. KHEIRON spinal implants are made of Ti-6AI-4V ELI alloy that conforms to ASTM F136. The KHEIRON Spinal Fixation System is provided clean, non-sterile, and the implants are single-use only.