aprevo® posterior/transforaminal lumbar interbody fusion device

The aprevo® posterior/transforaminal lumbar interbody fusion device is a patient-specific, additively manufactured titanium spinal implant designed to stabilize the lumbar spine and facilitate fusion. It is indicated for interbody fusion in skeletally mature patients with degenerative disc disease, disc herniation, spondylolisthesis, deformity, spinal stenosis, pseudarthrosis, or severe adult spinal deformity, and must be used with supplemental fixation systems and bone graft.

The device is manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 using additive manufacturing and incorporates patient-specific features with a bone graft aperture. Associated instruments are made from stainless steel per ASTM A564. The device is personalized based on patient radiological images to determine surgical correction plans and configurations.

ASTM F2077 (static and dynamic axial compression and compression-shear testing), ASTM F2267 (engineering analysis of subsidence), ASTM F3001 (titanium alloy additive manufacturing), and ASTM A564 (stainless steel for instruments).

The aprevo® posterior device is substantially equivalent because it shares the same intended use, operating principle, design, materials, biocompatibility, manufacturing approach, and sterility as the predicate devices (primarily K241332 aprevo® TLIF device and K241019 aprevo® TLIF-C). Non-clinical testing demonstrated equivalent mechanical performance through static/dynamic compression and subsidence analysis, and cadaveric validation confirmed the device performs as intended. The personalized geometry and posterior approach represent modifications to an established predicate design without changing the fundamental function or safety profile.