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FDA 510(k)

DePuy ATTUNE™ Total Knee System

K-Number: K242665 · 2024-11-01

ApplicantDepuy Orthopedics, Inc.
Decision Date2024-11-01
Product CodeOIY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy ATTUNE™ Total Knee System is a medical device manufactured by Depuy Orthopedics, Inc.. It received FDA 510(k) clearance on 2024-11-01 under approval 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. It is manufactured by Depuy Orthopedics, Inc.. The 510(k) number is K242665.

When was DePuy ATTUNE™ Total Knee System approved by the FDA?

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

What company makes DePuy ATTUNE™ Total Knee System?

DePuy ATTUNE™ Total Knee System is manufactured by Depuy Orthopedics, Inc..

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

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT04325022 Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA ACTIVE_NOT_RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED

Related PubMed Literature

PMID: 41209898 Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty. Cureus (2025) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 29258356 Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system. Accountability in research (2018) PMID: 28280294 Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices. Journal of health care finance (2016)

Related Devices (Code: OIY)

K201347DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, 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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