FDA 510(k)

DePuy ATTUNE™ Total Knee System

K-Number: K242665 · 2024-11-01

Decision Date2024-11-01

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 Orthopedics, Inc.. It received FDA 510(k) clearance on 2024-11-01 under 510(k) number K242665. 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 2024-11-01. The listed applicant is Depuy Orthopedics, Inc.. The 510(k) number is K242665.

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

DePuy ATTUNE™ Total Knee System received FDA 510(k) clearance on 2024-11-01, under 510(k) number K242665.

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

The FDA 510(k) record lists Depuy Orthopedics, 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 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.K201347DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.