FDA 510(k)

ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors

K-Number: K253197 · 2025-11-19

Decision Date2025-11-19

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2025-11-19 under approval number K253197. 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 Revision Sleeve LPS Femoral Adaptors?

ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors is a medical device that received FDA 510(k) clearance on 2025-11-19. It is manufactured by Depuy Ireland UC. The 510(k) number is K253197.

When was ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors approved by the FDA?

ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors received FDA 510(k) clearance on 2025-11-19, under approval number K253197.

What company makes ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors?

ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors is manufactured by Depuy Ireland UC.

What is the FDA product code for ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors?

The FDA product code for ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors is JWH.

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 NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07276815 OverStitch NXT Endoscopic Suture System NOT_YET_RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41460256 Benchmarking THA Implant Combinations Using Data From a US Total Joint Replacement Registry. Clinical orthopaedics and related research (2026)

Other Devices by Depuy Ireland UC

K170748GLOBAL UNITE Platform Shoulder System K202248Attune Revision Sleeve LPS Femoral Adaptors K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology K202098GLOBAL UNITE Platform Shoulder System K200854DePuy PINNACLE Dual Mobility Liner K193549SIGMA High Performance (HP) Partial Knee System

View all 48 devices →

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.