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FDA 510(k)

EVOLUTION Revision CCK System

K-Number: K171389 · 2017-08-08

ApplicantMicroport Orthopedics, Inc.
Decision Date2017-08-08
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOLUTION Revision CCK System is a medical device manufactured by Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2017-08-08 under approval number K171389. 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 Revision CCK System?

EVOLUTION Revision CCK System is a medical device that received FDA 510(k) clearance on 2017-08-08. It is manufactured by Microport Orthopedics, Inc.. The 510(k) number is K171389.

When was EVOLUTION Revision CCK System approved by the FDA?

EVOLUTION Revision CCK System received FDA 510(k) clearance on 2017-08-08, under approval number K171389.

What company makes EVOLUTION Revision CCK System?

EVOLUTION Revision CCK System is manufactured by Microport Orthopedics, Inc..

What is the FDA product code for EVOLUTION Revision CCK System?

The FDA product code for EVOLUTION Revision CCK System is JWH.

Related Clinical Trials

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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 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 K182125EVOLUTION Stemmed CS Femur

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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