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Microport Orthopedics, Inc. FDA Approvals

0 new drug approvals and 13 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
EVOLUTION® AM BIOFOAM® Tibial System510(k)Aug 21, 2026Orthopedic
NEXUS® Hip Stem510(k)May 15, 2025Orthopedic
Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique510(k)Feb 18, 2025Orthopedic
Ceramic Femoral Head510(k)Apr 12, 2024Orthopedic
EVOLUTION® 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 Inse510(k)Apr 1, 2024Orthopedic
EVOLUTION® Tibial Cones510(k)Jan 18, 2024Orthopedic
EVOLUTION® Cement Keel510(k)Oct 31, 2023Orthopedic
EVOLUTION® Hinge Knee System510(k)Sep 27, 2023Orthopedic
MPO Knee Instruments; MPO PROPHECY Knee Instruments510(k)Jan 5, 2022Orthopedic
MPO Hip Instruments510(k)Jan 5, 2022Orthopedic
E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS510(k)Oct 1, 2021Orthopedic
Prime BIOFOAM® Multi-Hole Shells510(k)Aug 24, 2021Orthopedic
Prime and DYNASTY® Additive Manufacturing Shells510(k)Aug 20, 2021Orthopedic

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