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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K213817
Device Name MPO Knee Instruments; MPO PROPHECY Knee Instruments
Applicant
Microport Orthopedics, Inc.
5677 Airline Rd.
Arlington,  TN  38002
Applicant Contact Gillen Gonzales
Correspondent
Microport Orthopedics, Inc.
5677 Airline Rd.
Arlington,  TN  38002
Correspondent Contact Gillen Gonzales
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
JWH   OOG  
Date Received12/07/2021
Decision Date 01/05/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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