restor3d has secured FDA 510(ok) clearance for its iTotal Id CR 3DP Porous Whole 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 Id 3D-printed cementless system combines patient-matched design with porous expertise for orthopedic functions. It consists of pre-navigated surgical devices that goal to cut back intraoperative guesswork, with all parts delivered in a sterile, single-use package. The system incorporates restor3d’s TIDAL Expertise on the femoral, tibial, and patellar parts.
“For the primary time, we have now a really patient-specific, cementless knee substitute choice, 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 affords optimized osseointegration energy and improved fatigue resistance in comparison with conventional truss-based lattices.
restor3d plans to work with orthopedic surgeons in the course of 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 customized orthopedic implants and holds mental property in osseointegrative supplies and AI-based planning instruments.
