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FDA 510(k)

Persona the Personalized Knee System

K-Number: K243247 · 2024-10-29

ApplicantZimmer, Inc.
Decision Date2024-10-29
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Persona the 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 2024-10-29 under 510(k) number K243247. 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 Persona the Personalized Knee System?

Persona the Personalized Knee System is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is Zimmer, Inc.. The 510(k) number is K243247.

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

Persona the Personalized Knee System received FDA 510(k) clearance on 2024-10-29, under 510(k) number K243247.

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

The FDA product code for Persona the 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 ROSARECRUITINGNCT04817969Persona 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.

PMA P060037Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearingK261683Augment Off-Axis Instrument SystemK260831Z1 Hip SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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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.

K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.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.

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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