Endoskeleton™ Interbody Systems

The Endoskeleton™ Interbody Systems are titanium alloy spinal fusion implants with a hollow center designed to house bone graft material. They are indicated for use in spinal fusion procedures across lumbar, thoracolumbar, and cervical regions in patients with degenerative disc disease, spondylolisthesis, or spinal stenosis, with some variants designed for vertebral body replacement or standalone use with integrated screws.

The subject devices have identical intended use, fundamental scientific technology, materials, sizing, and sterilization methods as the predicate Endoskeleton™ Interbody System (K211258). The primary difference is the addition of MR Conditional labeling, indicating the devices can be safely imaged in magnetic resonance environments under specified conditions.

ASTM F2503-23 (MR safety marking), ASTM F2182-19a (RF heating measurement), ASTM F2052-21 (magnetically induced displacement force), ASTM F2213-17 (magnetically induced torque), ASTM F2119-24 (MR image artifacts), and Medtronic's proprietary PR20066A MRI testing protocol for RF heating, force, torque, and image distortion.

The devices are substantially equivalent because they retain all material, design, sizing, and sterilization characteristics of the predicate while adding only labeling information. The MR Conditional status is supported by comprehensive testing demonstrating safe imaging conditions and is a labeling claim, not a fundamental design change; therefore the devices perform the same intended function with the same mechanism of action as the predicate.