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FDA 510(k)

MPO Knee Instruments; MPO PROPHECY Knee Instruments

K-Number: K213817 · 2022-01-05

ApplicantMicroport Orthopedics, Inc.
Decision Date2022-01-05
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MPO Knee Instruments; MPO PROPHECY Knee Instruments is a medical device manufactured by Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2022-01-05 under approval number K213817. 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 MPO Knee Instruments; MPO PROPHECY Knee Instruments?

MPO Knee Instruments; MPO PROPHECY Knee Instruments is a medical device that received FDA 510(k) clearance on 2022-01-05. It is manufactured by Microport Orthopedics, Inc.. The 510(k) number is K213817.

When was MPO Knee Instruments; MPO PROPHECY Knee Instruments approved by the FDA?

MPO Knee Instruments; MPO PROPHECY Knee Instruments received FDA 510(k) clearance on 2022-01-05, under approval number K213817.

What company makes MPO Knee Instruments; MPO PROPHECY Knee Instruments?

MPO Knee Instruments; MPO PROPHECY Knee Instruments is manufactured by Microport Orthopedics, Inc..

What is the FDA product code for MPO Knee Instruments; MPO PROPHECY Knee Instruments?

The FDA product code for MPO Knee Instruments; MPO PROPHECY Knee Instruments is MBH.

Other Devices by Microport Orthopedics, Inc.

K152631MPO Total Knee Systems MR Labeling K171181PROCOTYL® PRIME E-CLASS™ XLPE Liner K171389EVOLUTION Revision CCK System K170444PROCOTYL® PRIME Acetabular Cup System K170288BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell K162026EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions

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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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