DeGen Medical Patient Specific Implant (PSI) System

The DeGen Medical Patient-Specific Implant (PSI) System comprises patient-specific lumbar interbody fusion spacers for anterior (Solar™ PSI) or posterior/transforaminal (Impulse™ PSI) spinal fusion procedures. These titanium implants are designed individually using patient imaging data and are indicated for treating degenerative disc disease, spondylolisthesis, and related spinal conditions in skeletally mature patients who have failed conservative treatment.

The subject device is identical in intended use, indications for use, design, and function to the predicate device (K241077). The key difference is the addition of a non-sterile implant offering to supplement the previously cleared sterile configuration, with minor supporting changes to manufacturing flow. All implants remain additively manufactured from Puri-Ti™ unalloyed titanium or Ti-6AL-4V ELI titanium alloy with variable patient-matched dimensions.

Steam sterilization validation per ISO 17665; cleaning validation using visual inspection, total organic carbon analysis per USP <643>, gravimetric residual particulate quantitation per ASTM F2459, and bacterial endotoxin testing per USP <85> and AAMI ST72; cytotoxicity testing per ISO 10993-5.

The submission demonstrates substantial equivalence by showing the subject device maintains identical intended use, indications for use, design, and function as the predicate. The only material change is offering a non-sterile configuration alongside the existing sterile version with supporting manufacturing modifications. Performance testing validates that the sterilization, cleaning, and biocompatibility characteristics are equivalent, establishing that the device is as safe and effective as the legally marketed predicate.