aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation

The aprevo® devices are personalized intervertebral fusion implants made of titanium alloy, designed to stabilize the lumbar spine and facilitate bone fusion. They are indicated for skeletally mature patients with degenerative disc disease, spinal deformity, stenosis, and other spinal conditions who have failed conservative treatment. The devices come in two variants: one for use with supplemental fixation systems, and another (ALIF-X) with integrated screws for standalone or supplemental use depending on the number of levels and degree of lordosis.

The subject devices have identical indications, mechanical properties, raw materials (Ti-6Al-4V ELI titanium), sterilization, and packaging as the predicate devices. The only difference is the addition of optional configurations. Manufacturing processes are identical, and mechanical testing confirmed equivalent mechanical properties to the predicates.

ASTM F2077 (static and dynamic compression, static and dynamic compression shear), ASTM F3001 (tensile testing, microstructure assessment, chemical composition), and cadaveric validation study.

The subject devices are substantially equivalent because they have the same intended use, indications for use, and mechanical properties as the legally marketed predicates. The manufacturing processes are identical, and mechanical testing demonstrated the subject devices perform with equivalent mechanical properties. The only difference—optional configurations—does not affect the devices' fundamental design, materials, or function, as supported by comprehensive non-clinical testing.