FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments

The FLASH™ Facet Fusion Instruments are a manually operated disposable instrument set designed for use with the 7D Surgical System during spinal surgery. They assist surgeons in precisely locating and preparing lumbar facet joints in open or minimally invasive procedures, and enable delivery of bone graft into the facet joint defect.

The subject instruments are specifically designed for use with the 7D Surgical System and are assembled and secured to a 7D Universal Array for image-guided surgery. Like the predicate, they use fundamental stereotactic technology and are made of stainless steel and medical-grade plastics. Unlike the primary predicate, the subject instruments are optimized for facet joint preparation rather than general navigation, similar to the reference predicate.

ISO 10993-1 (biological evaluation), ISO 11607-1 and -2 (packaging), ISO 11137-1, -2, and -3 (radiation sterilization), IEC 62366-1 (usability engineering), ANSI/AAMI HE75 (human factors engineering), ASTM F2554-22 (positional accuracy of computer-assisted surgical systems), and ISO 14971 (risk management).

The subject device is substantially equivalent because it shares the same intended use (image-guided facet joint preparation), principle of operation (stereotactic guidance via the 7D Surgical System), materials, and design features as the predicate SeaSpine 7D Navigation Instruments. The minor technological difference—optimization for facet joint rather than general navigation—does not raise new safety or effectiveness issues since bench performance testing and human factors validation confirmed equivalent functionality and the underlying stereotactic technology is unchanged.