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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 the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2022-01-05 under 510(k) 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. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K213817.

When did MPO Knee Instruments; MPO PROPHECY Knee Instruments receive FDA 510(k) clearance?

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

Who is the listed applicant for MPO Knee Instruments; MPO PROPHECY Knee Instruments?

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

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 records listing Microport Orthopedics, Inc. as applicant

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.

K250444NEXUS® Hip StemK243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueK240046Ethylene Oxide Sterilization Supplier Change for MPO HipsK240452Ceramic Femoral HeadK240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial InseK233507EVOLUTION® Tibial Cones

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Related Devices (Code: MBH)

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.

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 OrthopaedicsK253239Active-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.

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