aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams

The aprevo® devices are personalized spinal fusion interbodies for the lumbar and cervical spine, manufactured from titanium alloy using patient-specific 3D surgical planning based on CT scans. They are indicated to stabilize the spinal column and facilitate bone fusion in skeletally mature patients with degenerative disc disease, deformity, stenosis, and other spinal conditions, and must be used with supplemental fixation and bone graft.

The devices are manufactured from Ti-6Al-4V titanium alloy per ASTM F3001; screws are machined from material per ASTM F136. Design features including height, footprint, angulation, screw configurations, and inserter configurations are identical to predicate devices. The devices incorporate patient-specific features with an aperture for bone graft packing and are provided as single-use, sterile-packed products with an inserter instrument.

ASTM F3001 (titanium alloy specification); ASTM F136 (titanium alloy for surgical implants); DICE score statistical analysis with acceptance criterion >0.80 for imaging expiration validation.

The subject devices are substantially equivalent because they are identical to the predicate devices in intended use (spinal fusion), indications for use (same degenerative conditions), manufacturing methods (additive manufacturing from titanium), materials (Ti-6Al-4V per ASTM F3001), and technological features (dimensions, design, screw configurations). The only change is extension of imaging expiration dating for 3D surgical planning, validated through clinical data and statistical analysis; no changes were made to the underlying surgical planning software itself.