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FDA 510(k)

EVOLUTION® Hinge Knee System

K-Number: K230563 · 2023-09-27

ApplicantMicroport Orthopedics, Inc.
Decision Date2023-09-27
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOLUTION® Hinge Knee System is a medical device manufactured by Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2023-09-27 under approval number K230563. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVOLUTION® Hinge Knee System?

EVOLUTION® Hinge Knee System is a medical device that received FDA 510(k) clearance on 2023-09-27. It is manufactured by Microport Orthopedics, Inc.. The 510(k) number is K230563.

When was EVOLUTION® Hinge Knee System approved by the FDA?

EVOLUTION® Hinge Knee System received FDA 510(k) clearance on 2023-09-27, under approval number K230563.

What company makes EVOLUTION® Hinge Knee System?

EVOLUTION® Hinge Knee System is manufactured by Microport Orthopedics, Inc..

What is the FDA product code for EVOLUTION® Hinge Knee System?

The FDA product code for EVOLUTION® Hinge Knee System is KRO.

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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

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: KRO)

K163311GMK Revision Femoral Distal AugmentationMedacta International S.A. K161520ELEOS Limb Salvage SystemOnkos Surgical, Inc. K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coatingWaldemar Link GmbH & Co. KG K172347GMK Hinge, GMK RevisionMedacta International S.A. K190181Instruments for LINK MEGASYSTEM-C FamilyLinkBio Corp. K191779Attune Revision LPS InsertsDepuy(Ireland)

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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