Cleared Special

MPO Knee Instruments; MPO PROPHECY Knee Instruments

K213817 · Microport Orthopedics, Inc. · Orthopedic
Jan 2022
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K213817 is an FDA 510(k) clearance for the MPO Knee Instruments; MPO PROPHECY Knee Instruments, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on January 5, 2022, 29 days after receiving the submission on December 7, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number K213817 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2021
Decision Date January 05, 2022
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3565

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