VantageTM Lumbar Decompression Kit

The Vantage™ Lumbar Decompression Kit is a sterile, single-use surgical instrument kit designed to perform lumbar spine decompression procedures for treating various spinal conditions. It includes specialized instruments that can access and remove bone and soft tissue, supports multiple procedural approaches (open and indirect visualization), and contains a disposable light source for visualization.

The subject device includes similar instruments to the predicate system but incorporates different materials. Both devices are composed of specialized instruments intended for lumbar decompression procedures, though technological differences exist in material composition and instrument design.

ISO 10993-1 (biocompatibility including cytotoxicity, sensitization, irritation, acute system, and pyrogenicity), ISO 11137 (sterilization validation), ASTM D4169 and ASTM F2096 (packaging validation), ISO 11607 (packaging), ASTM F1877 (particulate assessment), and cadaveric testing.

The subject device shares the same intended use as the predicate device for performing lumbar decompression procedures. Both include specialized instruments for treating spinal conditions. Performance testing demonstrates that differences in technological characteristics and materials do not raise questions of safety and effectiveness, establishing substantial equivalence to the ELID System predicate device.