IVA & AEON Cervical and Lumbar Cage System

The IVA & AEON Cervical and Lumbar Cage System are intervertebral fusion devices implanted between vertebral bodies to achieve spinal fusion and mechanical stability. The cervical versions (IVA-C and AEON-C) treat degenerative disc disease of the cervical spine at one or two contiguous levels (C2-T1), while the lumbar versions (IVA-L and AEON-L) treat lumbar degenerative disc disease with up to Grade 1 spondylolisthesis at one or two continuous levels (L2-S1). All versions require patients to have completed at least six weeks (cervical) or six months (lumbar) of non-operative treatment prior to implantation.

The cages are manufactured via Selective Laser Melting (SLM) 3D printing using medical-grade titanium alloy powder per ASTM F3001, or by machining from titanium alloy per ASTM F136 or PEEK per ASTM F2026. Associated screws are manufactured from titanium alloy per ASTM F136. Instruments are made from stainless steel per ASTM F899. All components are provided non-sterile and require steam sterilization by the end user prior to use. The design features, materials, and sterilization approach are identical to currently marketed predicate devices.

Non-clinical testing included static and dynamic compression bending (ASTM F2077), static and dynamic compression shear bending (ASTM F2077), static and dynamic torsion (ASTM F2077), and subsidence testing (ASTM F2267). No clinical tests were conducted. The materials comply with ASTM F3001, F136, F2026, and F899 standards for orthopedic implants and instruments.

Substantial equivalence is established through identical intended use (intervertebral body fusion), identical indications for use, and identical materials and design features compared to multiple predicate devices including the IVA-C/IVA-L cages and the AEON-C cage. The non-clinical performance testing demonstrates the device will function within intended uses with mechanical properties similar to predicates. Since the manufacturing methods (SLM 3D printing or CNC machining), materials, sterilization approach, and design are all comparable to already-cleared predicates, and no new safety or effectiveness issues are raised by the testing data, the device meets the substantial equivalence standard.