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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 the device name listed in this FDA 510(k) record. The listed applicant is Depuy(Ireland). It received FDA 510(k) clearance on 2016-06-10 under 510(k) 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. The listed applicant is Depuy(Ireland). The 510(k) number is K160700.

When did ATTUNE Revision Knee System receive FDA 510(k) clearance?

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

Who is the listed applicant for ATTUNE Revision Knee System?

The FDA 510(k) record lists Depuy(Ireland) as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03153449ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty PopulationACTIVE_NOT_RECRUITINGNCT03153475ATTUNE Revision System in the Revision Total Knee Arthroplasty PopulationACTIVE_NOT_RECRUITING

Other records listing Depuy(Ireland) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212683GLOBAL ICON Stemless Shoulder SystemK192855DELTA XTEND(TM) Reverse Shoulder SystemK190344DePuy Corail AMT Hip ProsthesisK191779Attune Revision LPS InsertsK192448Delta Xtend Revers Shoulder SystemK183077Delta Xtend Reverse Shoulder System

View all 9 devices →

Related Devices (Code: JWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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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