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FDA 510(k)

Porous Patella and Porous Tibia Baseplate

K-Number: K211221 · 2021-10-01

ApplicantSmith & Nephew, Inc.
Decision Date2021-10-01
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Porous Patella and Porous Tibia Baseplate is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2021-10-01 under approval number K211221. 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 Porous Patella and Porous Tibia Baseplate?

Porous Patella and Porous Tibia Baseplate is a medical device that received FDA 510(k) clearance on 2021-10-01. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K211221.

When was Porous Patella and Porous Tibia Baseplate approved by the FDA?

Porous Patella and Porous Tibia Baseplate received FDA 510(k) clearance on 2021-10-01, under approval number K211221.

What company makes Porous Patella and Porous Tibia Baseplate?

Porous Patella and Porous Tibia Baseplate is manufactured by Smith & Nephew, Inc..

What is the FDA product code for Porous Patella and Porous Tibia Baseplate?

The FDA product code for Porous Patella and Porous Tibia Baseplate is MBH.

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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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