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 the device name listed in this FDA 510(k) record. The listed applicant is Restor3D, Inc.. It received FDA 510(k) clearance on 2025-03-27 under 510(k) 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. The listed applicant is Restor3D, Inc.. The 510(k) number is K243768.

When did iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System receive FDA 510(k) clearance?

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

Who is the listed applicant for iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System?

The FDA 510(k) record lists Restor3D, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07563803The restor3d Outcomes RegistryNOT_YET_RECRUITING NCT02525601Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining - Cemented vs. UncementedACTIVE_NOT_RECRUITING NCT0283985014022 ATTUNE Cementless RP Clinical Performance EvaluationACTIVE_NOT_RECRUITING NCT04103502In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune PCR TKAWITHDRAWN NCT07533188Patient Outcomes Following Kinematic and Functional Alignment in Robotic-Assisted Total Knee Arthroplasty With Randomized Insert TypesRECRUITING

Other records listing Restor3D, Inc. as applicant

K260556Veritas Shoulder System K253992Veritas Reverse Total Shoulder System K252067Velora Acetabular System K252454Kinos Total Ankle System K243643restor3d Reverse Total Shoulder Arthroplasty System K242356TIDAL Fusion Cage System

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Related Devices (Code: MBH)

K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.

Official Source

View on FDA Database →

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