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FDA 510(k)

EVOLUTION® Cement Keel

K-Number: K231947 · 2023-10-31

ApplicantMicroport Orthopedics, Inc.
Decision Date2023-10-31
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOLUTION® Cement Keel is a medical device manufactured by Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2023-10-31 under approval number K231947. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVOLUTION® Cement Keel?

EVOLUTION® Cement Keel is a medical device that received FDA 510(k) clearance on 2023-10-31. It is manufactured by Microport Orthopedics, Inc.. The 510(k) number is K231947.

When was EVOLUTION® Cement Keel approved by the FDA?

EVOLUTION® Cement Keel received FDA 510(k) clearance on 2023-10-31, under approval number K231947.

What company makes EVOLUTION® Cement Keel?

EVOLUTION® Cement Keel is manufactured by Microport Orthopedics, Inc..

What is the FDA product code for EVOLUTION® Cement Keel?

The FDA product code for EVOLUTION® Cement Keel is JWH.

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

View all 28 devices →

Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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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