HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES

The HC BIOLOGICS OSTEOPOINT PEEK CAGES are intervertebral body fusion devices designed to maintain intervertebral space height and support bone fusion in cervical and lumbar spine. The cervical cages are used after decompression for degenerative disc disease with radicular symptoms at one level (C2-T1), while lumbar cages are used for one or two contiguous levels (L2-S1) in patients with degenerative disc disease and up to Grade 1 spondylolisthesis. Both are implanted via anterior approach with supplemental fixation and autologous bone graft.

The devices are composed of PEEK (ASTM F2026) for the cage body and titanium alloy Ti6Al4V ELI (ASTM F136) for pins, markers, screws, and expansion mechanisms. They are available in different shapes and sizes and are designed to maintain intervertebral space height during spinal fusion procedures. The devices have the same materials, design, function, range of sizes, manufacturing processes, surgical techniques, and intended use as the predicate device.

Testing was performed according to ASTM F2007 (Static Axial Compression Test), Static Axial Compression Shear Test, Static Torsion Test, Dynamic Axial Compression Shear Test, Dynamic Torsion Test, and ASTM F2267 (Subsidence). The materials comply with ASTM F2026 for PEEK and ASTM F136 for titanium alloy.

The HC Biologics Osteopoint Peek Cages have the same indications for use, technological characteristics, materials, design, and function as the predicate device (MSFX MIKRON PEEK CAGES, K252781). Biomechanical testing demonstrated substantial equivalence in performance, demonstrating that the subject device is as safe, effective, and performs as well as the legally marketed predicate devices.