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RANGE /DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications: Non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis: curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor: pseudarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion. Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA and DENALI®) Spinal Systems, all of which are cleared for the following indications: Non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation): spinal stenosis: curvatures (i.e.. scoliosis, kyphosis and/or lordosis); tumor: pseudarthrosis; and/or failed previous fusion. Except for hooks. when used as an anterolaicral thoracic/lumbar system the Everest Spinal System may also be used for the same indications as an adjunct to fusion. When used for posterior non-cervical pedicle screw fixation in pcdiatric patients the Everest Spinal System implants arc indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices arc to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Range and Everest Spinal Systems are top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consist of pedicle screws, rods, locking set screws, hooks, rod connectors and transverse connectors.

Materials: The devices are manufactured from Titanium Alloy and Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of the posterior thoracic and lumbar spine.

This submission is for a spinal fixation system, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, and training set information is not applicable.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design features, materials, intended use, and mechanical performance testing (static compression, static torsion, and dynamic compression in accordance with ASTM F1717). The "acceptance criteria" here refer to the device's ability to meet these established ASTM standards and demonstrate equivalence to previously cleared devices.

Summary of Relevant Information from the Provided Text:

• Device: Range Spinal System, Everest Spinal System (spinal fixation systems)
• Purpose of Submission: To expand the indications for use for these systems.
• Performance Data: The Range and Everest Spinal System components were previously tested in static compression, static torsion, and dynamic compression in accordance with ASTM F1717.
• Conclusion: The devices were determined to be substantially equivalent to predicate devices based on these tests and a review of literature concluding expanded indications do not result in new safety/effectiveness issues.
• Regulatory Class: Class III

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