restor3d has secured FDA 510(ok) clearance for its iTotal Identification CR 3DP Porous Complete Knee Substitute System. The brand new system represents the corporate’s first cementless providing in its patient-specific implant portfolio following the acquisition of Conformis. A restricted market launch is deliberate for the third quarter of 2025.
The Identification 3D-printed cementless system combines patient-matched design with porous know-how for orthopedic purposes. It contains pre-navigated surgical devices that purpose to scale back intraoperative guesswork, with all elements delivered in a sterile, single-use package. The system incorporates restor3d’s TIDAL Expertise on the femoral, tibial, and patellar elements.
“For the primary time, we’ve a very patient-specific, cementless knee alternative possibility, and that’s extremely thrilling,” stated Brian Palumbo, MD at Florida Orthopaedic Institute, Florida. “The cementless tibial baseplate is designed for optimum stability and fixation, offering most protection with out overhang or compromise in rotational alignment.”
The system options strategically positioned peripheral pegs on the tibial baseplate to reinforce stability whereas avoiding impingement with the tibial cortex. In response to the corporate, the TIDAL Expertise gives optimized osseointegration power and improved fatigue resistance in comparison with conventional truss-based lattices.
restor3d plans to work with orthopedic surgeons throughout the restricted launch part to guage the system’s efficiency and affected person outcomes. The Durham, North Carolina-based firm makes a speciality of 3D-printed personalised orthopedic implants and holds mental property in osseointegrative supplies and AI-based planning instruments.
