Cleared Traditional

MOTO PFJ System

K200122 · Medacta International S.A. · Orthopedic

Apr 2020

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K200122 is an FDA 510(k) clearance for the MOTO PFJ System, a Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRR), submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on April 20, 2020, 90 days after receiving the submission on January 21, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3540.

Submission Details

510(k) Number	K200122 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 21, 2020
Decision Date	April 20, 2020
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KRR — Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3540