aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra® cervical plating system

The aprevo® interbody fusion systems (anterior/lateral lumbar, posterior/transforaminal lumbar, and cervical variants) and corra™ cervical plating system are spinal implants designed to stabilize the spine and facilitate fusion. These personalized devices incorporate patient-specific features developed from radiological images and are indicated for treating degenerative disc disease, deformity, stenosis, and other spinal conditions in skeletally mature patients who have failed conservative treatment.

The devices are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001) for interbody components and titanium alloy (Ti-6Al-4V ELI per ASTM F136) for screws and plates. Key differences from predicates include addition of non-sterile instrument configurations that have the same design, functions, and instrument/implant interface as previously cleared sterile instruments, with no questions of safety or effectiveness raised by these additions.

Non-clinical testing included cleaning per ISO 17664-1 and ANSI AAMI ST98, and sterilization per ISO 17665 and ANSI AAMI ST79. Biocompatibility and non-clinical testing were performed to demonstrate substantially equivalent performance.

Substantial equivalence is established through comparison of intended use, indications for use, technological characteristics, operating principle, design and components, materials, manufacturing, biocompatibility, packaging, labeling, and non-clinical testing. The subject systems demonstrate equivalent performance to predicate devices, with the only difference being the addition of non-sterile instrument configurations that do not raise safety or effectiveness concerns due to identical design and interface characteristics.