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FDA 510(k)

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology

K-Number: K232303 · 2023-12-11

ApplicantDepuy Ireland UC
Decision Date2023-12-11
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2023-12-11 under approval number K232303. 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 ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology?

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology is a medical device that received FDA 510(k) clearance on 2023-12-11. It is manufactured by Depuy Ireland UC. The 510(k) number is K232303.

When was ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology approved by the FDA?

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology received FDA 510(k) clearance on 2023-12-11, under approval number K232303.

What company makes ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology?

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology is manufactured by Depuy Ireland UC.

What is the FDA product code for ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology?

The FDA product code for ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology is MBH.

Related Clinical Trials

NCT00435357 Comparison Between Fixed- Versus Mobile-bearing TKA COMPLETED NCT03153449 ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT05428332 Spring Loaded Tri-Compartment Unloader Knee Brace Study COMPLETED NCT03720782 Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT07092579 Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures RECRUITING

Other Devices by Depuy Ireland UC

K170748GLOBAL UNITE Platform Shoulder System K202248Attune Revision Sleeve LPS Femoral Adaptors K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology K202098GLOBAL UNITE™ Platform Shoulder System K200854DePuy PINNACLE Dual Mobility Liner K193549SIGMA High Performance (HP) Partial Knee System

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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

View on FDA Database →

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

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