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FDA 510(k)

ATTUNE Revision Knee System

K-Number: K160700 · 2016-06-10

ApplicantDepuy(Ireland)
Decision Date2016-06-10
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ATTUNE Revision Knee System is a medical device manufactured by Depuy(Ireland). It received FDA 510(k) clearance on 2016-06-10 under approval number K160700. 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 ATTUNE Revision Knee System?

ATTUNE Revision Knee System is a medical device that received FDA 510(k) clearance on 2016-06-10. It is manufactured by Depuy(Ireland). The 510(k) number is K160700.

When was ATTUNE Revision Knee System approved by the FDA?

ATTUNE Revision Knee System received FDA 510(k) clearance on 2016-06-10, under approval number K160700.

What company makes ATTUNE Revision Knee System?

ATTUNE Revision Knee System is manufactured by Depuy(Ireland).

What is the FDA product code for ATTUNE Revision Knee System?

The FDA product code for ATTUNE Revision Knee System is JWH.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03153449 ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT02839850 14022 ATTUNE Cementless RP Clinical Performance Evaluation ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING

Other Devices by Depuy(Ireland)

K160907DePuy Actis DuoFix Hip Prosthesis K170806ATTUNE Cemented Tibial Base, Fixed Bearing K190344DePuy Corail AMT Hip Prosthesis K191779Attune Revision LPS Inserts K192448Delta Xtend Revers Shoulder System K183077Delta Xtend Reverse Shoulder System

View all 9 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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