Fine TTO™

Fine TTO™ is a patient-specific surgical system designed for tibial tuberosity osteotomies in skeletally mature patients. It uses advanced imaging (X-rays and CT scans) to create patient-specific cutting guides that assist surgeons in precise bone cutting and repositioning to improve knee mechanics and alignment.

Fine TTO™ employs patient-specific cutting guides made from biocompatible medical-grade polymers and titanium alloy screws (Ti-6Al-4V ELI) that conform precisely to individual patient bone anatomy. Like its predicate, it uses patient-specific guides and titanium implants, but Fine TTO™ is specifically designed for tibial tuberosity osteotomies and relies on screw fixation without a bone plate, whereas Fine Osteotomy addresses broader femoral and tibial osteotomies.

ASTM F136 and ISO 5832-3 for titanium alloy biocompatibility and material properties; ASTM F543 for mechanical testing of screws. The device underwent cadaveric accuracy testing, debris assessment, dimensional stability testing post-reprocessing and transport, and intra- and inter-designer variability testing.

Fine TTO™ is substantially equivalent to its predicate Fine Osteotomy (K241356) because both employ the same core technology of patient-specific surgical guides and titanium implants for precise bone cutting and fixation. Although Fine TTO™ is specialized for tibial tuberosity adjustments rather than broader osteotomies, this represents a more focused application of existing technology within the same anatomical region, not a new or untested technology. All non-clinical tests confirmed substantial equivalence with the predicate.