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FDA OKs restor3d’s iTotal Identity 3D-Printed, Personalized TKR System

This is the company’s first cementless offering in its patient-specific implant portfolio.

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By: Sam Brusco

Associate Editor

restor3d has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its iTotal Identity CR 3DP (3D-printed) porous total knee replacement (TKR) system.

This is the company’s first cementless offering in its patient-specific implant portfolio. restor3d plans to release it on a limited basis in Q3 2025.

The Identity 3D-printed cementless system integrates patient-matched design with advanced 3D-printed porous technology. It offers an alternative to traditional fixation methods while keeping the benefits of a patient-specific implant, according to the company.

A pre-navigated surgical system boosts efficiency by removing intra-operative guesswork, with personalized surgical instruments and implants delivered in a sterile, single-use kit.

The system, which incorporates restor3d’s TIDAL technology, is available on the femoral, tibial, and patellar components. According to the company, TIDAL delivers optimized osseointegration strength, fatigue resistance, and load distribution compared to truss-based lattices.

“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. Its strategically placed peripheral pegs enhance stability while avoiding impingement with the tibial cortex, a key factor for long-term implant success. Combined with a femoral component that maintains the patient’s native joint mechanics, this system offers a more natural feel and function for patients undergoing knee replacement.”

Last week, restor3d received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Ossera AFX ankle fusion system, which features cutting-edge 3D printing and TIDAL technology.

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