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FDA 510(k)

Zimmer® Persona® Personalized Knee System

K-Number: K251840 · 2026-05-28

ApplicantZimmer, Inc.
Decision Date2026-05-28
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zimmer® Persona® Personalized Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K251840. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zimmer® Persona® Personalized Knee System?

Zimmer® Persona® Personalized Knee System is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Zimmer, Inc.. The 510(k) number is K251840.

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

Zimmer® Persona® Personalized Knee System received FDA 510(k) clearance on 2026-05-28, under 510(k) number K251840.

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

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

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

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

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.

NCT06089291Persona IQ Cohort StudyACTIVE_NOT_RECRUITINGNCT05391828Persona MC vs PS RCT With ROSARECRUITINGNCT03895489Effectiveness of the Journey Total Knee Arthroplasty Versus Two Standard of Care Total Knee Arthroplasty ProsthesesCOMPLETEDNCT04817969Persona Ti-Nidium Post-Market Clinical Follow-upACTIVE_NOT_RECRUITING

Other records listing Zimmer, Inc. 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.

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Related Devices (Code: MBH)

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.

K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc.

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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