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The EXPEDIUM 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 acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The subject EXPEDIUM™ Spine System components are designed to accept a 5.5mm rod and are available in various geometries and sizes. The EXPEDIUM™ Spine System also contains Class I manual surgical instruments, trays and cases and are exempt from premarket notification. Manufactured from ASTM F 136 implant grade titanium alloy.

This is a 510(k) premarket notification for the EXPEDIUM™ Spine System, a medical device. The provided text is a summary of the application and the FDA's response, not a study report for an AI device. Therefore, I cannot extract the requested information concerning acceptance criteria and a study proving a device meets those criteria, especially details related to AI, ground truth, expert opinions, or sample sizes for testing and training sets.

The document describes a mechanical spine system and references characterization data per ASTM F 1798, which is a standard for fatigue testing of spinal implants. It does not involve AI or any form of image analysis.

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