restor3d stated that the 510(k) clearance represents an advancement in its knee replacement technology. Credit: VPLAB / Shutterstock.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for restor3d’s cementless iTotal Identity CR 3DP Porous Total Knee Replacement System.

The company stated that this milestone represents an advancement in its knee replacement technology following the acquisition of Conformis in September 2023, as it introduces the first cementless option to the “patient-specific” implant portfolio.

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restor3d is preparing for a limited market release in the third quarter of this year, during which the company would work with orthopaedic surgeons, aiming to ensure that the system upholds the standards of reliability, performance, and patient outcomes.

The Identity 3D-printed cementless system is claimed to be built upon its personalised orthopaedics approach, integrating a “patient-matched” design with 3D-printed porous technology. As the initial cementless product in the Identity knee platform, it is claimed to offer an option to conventional fixation methods while retaining the advantages of a tailored implant.

The system features femoral, tibial, and patellar components and utilises restor3d’s TIDAL Technology, offering optimised osseointegration strength, enhanced fatigue resistance, and improved load distribution when compared to conventional truss-based lattices.

restor3d focuses on 3D printed patient-specific musculoskeletal implants. It claims intellectual property in the 3D printing of osseointegration materials, planning, AI-based design automation tools, and digital health solutions, all of which contribute to delivering data-informed care “optimised” for each patient.

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In June 2024, the company secured $70m in a financing round for advancing the development of its 3D-printed implants.

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