Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System

The Curiteva Porous PEEK system consists of multiple interbody fusion devices for spinal applications across cervical, thoracic, lumbar, and lumbosacral regions. The devices include cervical interbody systems, lumbar interbody systems, laminoplasty systems, and standalone ALIF systems, all designed to support intervertebral body fusion in skeletally mature patients with degenerative disc disease, spinal instability, or related conditions.

The implants feature a proprietary nanomaterial surface treatment with a uniform nanocrystalline hydroxyapatite layer approximately 10-20 nm thick, with individual crystals averaging 91.5 nm in length and 10 nm width. The surface demonstrates reduced contact angle and increased hydrophilicity compared to uncoated and micro-sized HA coated controls, meeting criteria for nanotechnology as outlined in FDA guidance.

Not stated in this summary.

The devices are substantially equivalent to their predicates based on identical indications for use, technological characteristics, design, function, and non-clinical in vitro performance testing demonstrating uniform nanoscale features and enhanced hydrophilicity. Each device type compares to its corresponding predicate device with no changes to intended use or fundamental design.