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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
510(k) Number K202705
Device Name Prime and DYNASTY® Additive Manufacturing Shells
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 Number888.3358
Classification Product Code
OQG  
Subsequent Product Codes
LPH   LZO   OQI  
Date Received09/16/2020
Decision Date 08/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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