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FDA 510(k)

Persona® Personalized Knee System

K-Number: K212129 · 2021-09-28

ApplicantZimmer Switzerland Manufacturing GmbH
Decision Date2021-09-28
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Persona® Personalized Knee System is a medical device manufactured by Zimmer Switzerland Manufacturing GmbH. It received FDA 510(k) clearance on 2021-09-28 under approval number K212129. 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® Personalized Knee System?

Persona® Personalized Knee System is a medical device that received FDA 510(k) clearance on 2021-09-28. It is manufactured by Zimmer Switzerland Manufacturing GmbH. The 510(k) number is K212129.

When was Persona® Personalized Knee System approved by the FDA?

Persona® Personalized Knee System received FDA 510(k) clearance on 2021-09-28, under approval number K212129.

What company makes Persona® Personalized Knee System?

Persona® Personalized Knee System is manufactured by Zimmer Switzerland Manufacturing GmbH.

What is the FDA product code for Persona® Personalized Knee System?

The FDA product code for Persona® Personalized Knee System is JWH.

Related Clinical Trials

NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT07607899 Virtual Reality for Pain and Well-Being in Older Adults NOT_YET_RECRUITING NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT07204925 Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1 RECRUITING NCT07492797 Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Zimmer Switzerland Manufacturing GmbH

K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate K253749Affixus® Natural Nail® Proximal Humeral System

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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