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FDA 510(k)

DePuy ATTUNE™ Total Knee System

K-Number: K201347 · 2020-06-18

ApplicantDePuy Orthopaedics, Inc.
Decision Date2020-06-18
Product CodeOIY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy ATTUNE™ Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2020-06-18 under 510(k) number K201347. The device is classified under product code OIY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DePuy ATTUNE™ Total Knee System?

DePuy ATTUNE™ Total Knee System is a medical device that received FDA 510(k) clearance on 2020-06-18. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K201347.

When did DePuy ATTUNE™ Total Knee System receive FDA 510(k) clearance?

DePuy ATTUNE™ Total Knee System received FDA 510(k) clearance on 2020-06-18, under 510(k) number K201347.

Who is the listed applicant for DePuy ATTUNE™ Total Knee System?

The FDA 510(k) record lists DePuy Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DePuy ATTUNE™ Total Knee System?

The FDA product code for DePuy ATTUNE™ Total Knee System is OIY.

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.

NCT0283985014022 ATTUNE Cementless RP Clinical Performance EvaluationACTIVE_NOT_RECRUITINGNCT03153449ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty PopulationACTIVE_NOT_RECRUITINGNCT03153475ATTUNE Revision System in the Revision Total Knee Arthroplasty PopulationACTIVE_NOT_RECRUITINGNCT06323980INHANCE Stemless Reverse Shoulder IDERECRUITINGNCT06631638EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))RECRUITING

Other records listing DePuy Orthopaedics, Inc. 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.

PMA P070026Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncementedK252887DePuy ATTUNE™ Knee SystemK231503CUPTIMIZE™ AdvancedK213839DePuy Corail AMT Hip ProsthesisK210167DELTA XTEND Reverse Shoulder SystemK203167DePuy Corail AMT Hip Prosthesis

View all 14 devices →

Related Devices (Code: OIY)

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.

K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc.K242665DePuy ATTUNE™ Total Knee SystemDepuy Orthopedics, Inc.

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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