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FDA grants 510(k) clearance for restor3d’s cementless knee replacement system

Summary by Medical Device Network
The FDA has granted 510(k) clearance for restor3d’s cementless iTotal Identity CR 3DP Porous Total Knee Replacement System.The post FDA grants 510(k) clearance for restor3d’s cementless knee replacement system appeared first on Medical Device Network.
DisclaimerThis story is only covered by news sources that have yet to be evaluated by the independent media monitoring agencies we use to assess the quality and reliability of news outlets on our platform. Learn more here.

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Medical Device NetworkMedical Device Network

FDA grants 510(k) clearance for restor3d’s cementless knee replacement system

The FDA has granted 510(k) clearance for restor3d’s cementless iTotal Identity CR 3DP Porous Total Knee Replacement System.The post FDA grants 510(k) clearance for restor3d’s cementless knee replacement system appeared first on Medical Device Network.

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3D Printing3D Printing

restor3d Receives FDA Clearance for Fully Personalized Total Knee Replacement System - 3D Printing

restor3d has secured FDA 510(k) clearance for its iTotal Identity CR 3DP Porous Total Knee Replacement System.

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Ortho Spine News | Your Trusted Voice for Medical Device Industry Ortho NewsOrtho Spine News | Your Trusted Voice for Medical Device Industry Ortho News

restor3d receives FDA Clearance for iTotal IdentityTM CR 3DP Porous Fully Personalized Total Knee Replacement System – Ortho Spine News

DURHAM, N.C., April 1, 2025 -(BUSINESS WIRE)- 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 compa

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Medical Device News MagazineMedical Device News Magazine

Restor3d Receives FDA Clearance For ITotal IdentityTM CR 3DP Porous Fully Personalized Total Knee Replacement System - Medical Device News Magazine

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.

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Medical Device News Magazine broke the news in on Tuesday, April 1, 2025.
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