Cleared Traditional

Persona? Personalized Knee System

K212129 · Zimmer Switzerland Manufacturing GmbH · Orthopedic

Sep 2021

Decision

82d

Days

Class 2

Risk

About This 510(k) Submission

K212129 is an FDA 510(k) clearance for the Persona? Personalized Knee System, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Zimmer Switzerland Manufacturing GmbH (Winterthur, CH). The FDA issued a Cleared decision on September 28, 2021, 82 days after receiving the submission on July 8, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K212129 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 08, 2021
Decision Date	September 28, 2021
Days to Decision	82 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560