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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 the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2021-08-25 under 510(k) 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. The listed applicant is Depuy Ireland UC. The 510(k) number is K211609.

When did ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert receive FDA 510(k) clearance?

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

Who is the listed applicant for ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert?

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

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

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.

NCT00435357Comparison Between Fixed- Versus Mobile-bearing TKACOMPLETEDNCT03153449ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty PopulationACTIVE_NOT_RECRUITINGNCT03153475ATTUNE Revision System in the Revision Total Knee Arthroplasty PopulationACTIVE_NOT_RECRUITINGNCT07199738A Multi-Center Study Assessing the Safety and Efficacy of the LEGION Medial Stabilized (MS) Insert in Patients Undergoing a Total Knee Arthroplasty (TKA)RECRUITING

Other records listing Depuy Ireland UC 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.

K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemK260480VELYS™ Robotic-Assisted SolutionK260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementK253624INHANCE™ Reverse Shoulder SystemK253551VELYS™ Hip NavigationK253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors

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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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