SCRIPT™ Implant System

The SCRIPT™ Implant System is a patient-specific lumbar interbody fusion device designed to provide structural stability after disc removal. It includes static, integrated, and expandable spacer designs made from titanium alloy, manufactured using additive manufacturing (3D printing) with patient-matched endplates to fit individual vertebral anatomy. The system also includes ExcelsiusGPS™ instruments for navigated surgical placement and is indicated for treating degenerative disc disease, disc herniation, spondylolisthesis, deformity, spinal stenosis, and failed previous fusion across thoracic, thoracolumbar, and lumbosacral spine levels.

The subject device shares the same technological characteristics as predicate devices including design, intended use, material composition (titanium alloy, PEEK polymer), function as an interbody fusion spacer, and range of sizes. Static spacers and expandable endplates are additively manufactured from titanium powder; expandable internal components use wrought titanium alloy and radiolucent PEEK; drive screws are cobalt chromium or titanium alloy.

Mechanical testing followed the Guidance for Industry and FDA Staff Class II Special Controls Guidance Document for Intervertebral Fusion Devices (June 12, 2007), ASTM F2077, and ASTM F2267. Testing included axial compression, compression shear, subsidence, and expulsion testing. Verification and validation included cadaveric usability testing, non-clinical system and software verification, and instrument integration testing with ExcelsiusGPS™ instruments.

The SCRIPT™ Lumbar Spacers are substantially equivalent to predicate devices (HEDRON™ and SABLE™ Expandable Spacer as primary predicates) based on identical technical characteristics, performance, and intended use. Mechanical testing demonstrates equivalence to predicate devices per established FDA guidance and ASTM standards, and verification and validation testing confirm performance requirements are met for the intended fusion application.