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FDA 510(k)

ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert

K-Number: K211609 · 2021-08-25

ApplicantDepuy Ireland UC
Decision Date2021-08-25
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2021-08-25 under approval number K211609. 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 Medial Stabilized (MS) Fixed Bearing (FB) Insert?

ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert is a medical device that received FDA 510(k) clearance on 2021-08-25. It is manufactured by Depuy Ireland UC. The 510(k) number is K211609.

When was ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert approved by the FDA?

ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert received FDA 510(k) clearance on 2021-08-25, under approval number K211609.

What company makes ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert?

ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert is manufactured by Depuy Ireland UC.

What is the FDA product code for ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert?

The FDA product code for ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert is JWH.

Related Clinical Trials

NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT05264389 Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction ACTIVE_NOT_RECRUITING NCT00435357 Comparison Between Fixed- Versus Mobile-bearing TKA COMPLETED 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

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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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