Persona® Personalized Knee System

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Zimmer Switzerland Manufacturing GmbH

The following data is part of a premarket notification filed by Zimmer Switzerland Manufacturing Gmbh with the FDA for Persona® Personalized Knee System.

Pre-market Notification Details

• Device ID: K212129
• 510k Number: K212129
• Device Name: Persona® Personalized Knee System
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: Zimmer Switzerland Manufacturing GmbH Sulzerallee 8 Winterthur, CH 8404
• Contact: Thomas Lincoln
• Correspondent: Anne-kathrin Born; Zimmer Switzerland Manufacturing GmbH Sulzerallee 8 Winterthur, CH 8404
• Product Code: JWH
• Subsequent Product Code: MBH
• Subsequent Product Code: OIY
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-07-08
• Decision Date: 2021-09-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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