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FDA 510(k)

ATTUNE Total Knee System; ATTUNE Cementless Knee System

K-Number: K261458 · 2026-06-25

ApplicantDePuy Ireland UC
Decision Date2026-06-25
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ATTUNE Total Knee System; ATTUNE Cementless Knee System 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 2026-06-25 under 510(k) number K261458. 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 Total Knee System; ATTUNE Cementless Knee System?

ATTUNE Total Knee System; ATTUNE Cementless Knee System is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is DePuy Ireland UC. The 510(k) number is K261458.

When did ATTUNE Total Knee System; ATTUNE Cementless Knee System receive FDA 510(k) clearance?

ATTUNE Total Knee System; ATTUNE Cementless Knee System received FDA 510(k) clearance on 2026-06-25, under 510(k) number K261458.

Who is the listed applicant for ATTUNE Total Knee System; ATTUNE Cementless Knee System?

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 Total Knee System; ATTUNE Cementless Knee System?

The FDA product code for ATTUNE Total Knee System; ATTUNE Cementless Knee System 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.

NCT0283985014022 ATTUNE Cementless RP Clinical Performance EvaluationACTIVE_NOT_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.

K260480VELYS™ 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 AdaptorsK251292RECLAIM Monobloc Revision Femoral Stem

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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.K261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NVK252974EMPOWR KneeEncore 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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