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FDA 510(k)

Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)

K-Number: K243724 · 2025-03-06

ApplicantZimmer, Inc.
Decision Date2025-03-06
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2025-03-06 under approval number K243724. 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 Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)?

Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) is a medical device that received FDA 510(k) clearance on 2025-03-06. It is manufactured by Zimmer, Inc.. The 510(k) number is K243724.

When was Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) approved by the FDA?

Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) received FDA 510(k) clearance on 2025-03-06, under approval number K243724.

What company makes Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)?

Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) is manufactured by Zimmer, Inc..

What is the FDA product code for Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)?

The FDA product code for Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) is JWH.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06087445 A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia COMPLETED NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED NCT07561372 Adaptive Recruitment Curve Analysis Using Bayesian Modeling NOT_YET_RECRUITING NCT06655844 Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain RECRUITING

Related PubMed Literature

PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

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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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