Calibrate Interbody Systems

The Calibrate Interbody Systems are expandable lumbar intervertebral body fusion devices designed for posterior or transforaminal surgical approaches. They treat symptomatic degenerative disc disease, degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels in skeletally mature patients from L1 to S1, requiring at least six months of prior non-operative treatment. The systems include titanium alloy and PEEK spacers with anti-migration teeth and grit-blast endplate surfaces, offered in standard and NanoTec (hydroxyapatite-coated) variants.

The subject devices feature titanium alloy (Ti-6Al-4V ELI per ASTM F136) and PEEK Optima LT1 (per ASTM F2026) interbody spacers with parallel expansion design, anti-migration teeth, and grit-blast bone-contacting endplate surfaces. The NanoTec variants include a 20-40 nanometer hydroxyapatite surface treatment providing nano-scale topography in addition to existing macro-/micro-scale topography. Design, function, intended use, and technology are substantially equivalent to predicates across CCX and PSX configurations.

ASTM F2077 (static and dynamic axial compression), ASTM F2077 (static and dynamic compression-shear), ASTM F2267 (static subsidence), and static push-out testing. These non-clinical tests were performed or referenced in predicate 510(k) submissions.

The subject Calibrate Interbody Systems are substantially equivalent to predicates (Calibrate LTX, Calibrate CCX, and Calibrate PSX) because they share identical intended use, indications for use, design, function, and technology. Nonclinical performance testing demonstrates equivalence using the same ASTM standards applied to predicates. The only material difference—the NanoTec hydroxyapatite surface treatment—represents an incremental surface enhancement that does not alter the fundamental fusion mechanism or clinical application.