DeGen Medical Patient Specific Implant (PSI) System

The DeGen Medical Patient-Specific Implant (PSI) System is a series of patient-specific lumbar interbody spacers designed for anterior (Solar™ PSI) or posterior/transforaminal (Impulse™ PSI) lumbar fusion procedures. The devices are additively manufactured from titanium and are intended for use in patients with degenerative disc disease, disc herniation, spondylolisthesis, deformity, spinal stenosis, and failed previous fusion at one or more lumbosacral spine levels.

The subject device expands the CT scan parameters suitable for design of patient-matched endplates. The devices are additively manufactured from Puri-Ti™ unalloyed titanium with porous endplates to mitigate subsidence and expulsion. Some variants include integrated fixation screws (Ti6AL-4V ELI per ASTM F136) or tusks. The design, function, indications for use, and intended use remain otherwise identical to the predicate device.

The submission cites ASTM F136 for titanium alloy screw material specifications. A cadaver validation study was performed to support substantial equivalence.

The subject device is substantially equivalent to the predicate (K250667) because the expansion of CT scan parameters for patient-matched endplate design does not impact the ability to implement the intended surgical plan. Technological design features, indications for use, function, and safety/effectiveness profile are identical to the predicate device, as demonstrated by cadaver validation testing.