FDA 510(k)

iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System

K-Number: K243768 · 2025-03-27

Decision Date2025-03-27

Product CodeMBH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System is a medical device manufactured by Restor3D, Inc.. It received FDA 510(k) clearance on 2025-03-27 under approval number K243768. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System?

iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System is a medical device that received FDA 510(k) clearance on 2025-03-27. It is manufactured by Restor3D, Inc.. The 510(k) number is K243768.

When was iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System approved by the FDA?

iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System received FDA 510(k) clearance on 2025-03-27, under approval number K243768.

What company makes iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System?

iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System is manufactured by Restor3D, Inc..

What is the FDA product code for iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System?

The FDA product code for iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System is MBH.

Related Clinical Trials

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Related PubMed Literature

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Other Devices by Restor3D, Inc.

K201314Restor3d Utility Wedge K201393restor3d MTP Implant K240591restor3d Kinos Axiom Total Ankle System K252067Velora Acetabular System K242356TIDAL Fusion Cage System

Related Devices (Code: MBH)

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K171365Arthrex Knee SystemsArthrex, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.