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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 the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Switzerland Manufacturing GmbH. It received FDA 510(k) clearance on 2021-09-28 under 510(k) 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. The listed applicant is Zimmer Switzerland Manufacturing GmbH. The 510(k) number is K212129.

When did Persona® Personalized Knee System receive FDA 510(k) clearance?

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

Who is the listed applicant for Persona® Personalized Knee System?

The FDA 510(k) record lists Zimmer Switzerland Manufacturing GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT04817969Persona Ti-Nidium Post-Market Clinical Follow-upACTIVE_NOT_RECRUITINGNCT06089291Persona IQ Cohort StudyACTIVE_NOT_RECRUITING

Other records listing Zimmer Switzerland Manufacturing GmbH 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.

K253749Affixus® Natural Nail® Proximal Humeral SystemK241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft PlateK231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System

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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