restor3d has secured FDA 510(k) clearance for its iTotal Identity CR 3DP Porous Total Knee Replacement System. The new system represents the company’s first cementless offering in its patient-specific implant portfolio following the acquisition of Conformis. A limited market release is planned for the third quarter of 2025.
The Identity 3D-printed cementless system combines patient-matched design with porous technology for orthopedic applications. It includes pre-navigated surgical instruments that aim to reduce intraoperative guesswork, with all components delivered in a sterile, single-use kit. The system incorporates restor3d’s TIDAL Technology on the femoral, tibial, and patellar components.
“For the first time, we have a truly patient-specific, cementless knee replacement option, and that’s incredibly exciting,” said Brian Palumbo, MD at Florida Orthopaedic Institute, Florida. “The cementless tibial baseplate is designed for optimal stability and fixation, providing maximum coverage without overhang or compromise in rotational alignment.”
The system features strategically placed peripheral pegs on the tibial baseplate to enhance stability while avoiding impingement with the tibial cortex. According to the company, the TIDAL Technology offers optimized osseointegration strength and improved fatigue resistance compared to traditional truss-based lattices.
restor3d plans to work with orthopedic surgeons during the limited release phase to evaluate the system’s performance and patient outcomes. The Durham, North Carolina-based company specializes in 3D-printed personalized orthopedic implants and holds intellectual property in osseointegrative materials and AI-based planning tools.