Title restor3d receives FDA Clearance for iTotal IdentityTM CR 3DP Porous Fully Personalized Total Knee Replacement System

restor3d, a leader in 3D-printed, personalized orthopedic implant care, has received FDA 510(k) clearance for the iTotal Identity™ CR 3DP Porous Total Knee Replacement System. This milestone marks a significant achievement in expanding restor3d’s knee replacement technology since the acquisition of Conformis, introducing the first cementless offering to the patient-specific implant portfolio. The company plans a limited market release in Q3 of 2025.

The Identity 3D-printed cementless system is built on restor3d’s proven approach to personalized orthopedics, integrating patient-matched design with advanced 3D-printed porous technology. As the first cementless addition to the Identity knee platform, it provides an alternative to traditional fixation methods while preserving the benefits of a patient-specific implant. The pre-navigated surgical system enhances efficiency by eliminating intraoperative guesswork, with personalized surgical instruments and implants delivered in a sterile, single-use kit.

“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.”

Available on the femoral, tibial, and patellar components, the system incorporates restor3d’s TIDAL Technology delivering market leading optimized osseointegration strength¹, offering superior fatigue resistance and load distribution compared to traditional truss-based lattices.

restor3d will continue working closely with leading orthopedic surgeons during the limited market release in Q3 2025, ensuring that the Identity Personalized Knee Cementless System meets the highest standards of performance, reliability, and patient outcomes.

¹ Kelly CN, Wang T, Crowley J, Wills D, Pelletier MH, Westrick ER, Adams SB, Gall K, Walsh WR. High-strength, porous additively manufactured implants with optimized mechanical osseointegration. Biomaterials. 2021 Dec;279:121206. doi: 10.1016/j.biomaterials.2021.121206. Epub 2021 Oct 22. PMID: 34715639.

About restor3d, Inc.

restor3d is a world leader in 3D printed patient specific musculoskeletal implants and driven by the belief that every patient deserves personalized care. The company holds proprietary expertise and intellectual property in 3D printing of osseointegrative materials, AI-based planning and design automation tools, and digital health solutions to provide seamless data-backed care to optimize individual patient outcomes. Alongside its customers, restor3d is reimagining the musculoskeletal reconstruction landscape. More information is available at www.restor3d.com.

Forward Looking Statements

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“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.