FDA 510(k) Applications Submitted by MICROPORT ORTHOPEDICS, INC.

FDA 510(k) Number	Submission Date	Device Name	Applicant
K150133	01/21/2015	PROFEMUR Preserve Size 1-3 Hip Stems	MICROPORT ORTHOPEDICS, INC.
K162026	07/22/2016	EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions	MicroPort Orthopedics, Inc.
K152298	08/13/2015	EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base	MICROPORT ORTHOPEDICS, INC.
K170288	01/30/2017	BIOFOAM« Additive Manufacturing (BIOFOAM« AM), ADVANCE« BIOFOAM« Tibial Base, EVOLUTION« BIOFOAM« Tibial Base, DYNASTY« BIOFOAM« Acetabular Shell	MicroPort Orthopedics, Inc.
K180317	02/05/2018	EVOLUTION« Knee Systems û MR Labeling, EVOLUTION« BIOFOAM« Tibial System, EVOLUTION« Revision Tibial System, EVOLUTION« Revision CCK System	MicroPort Orthopedics, Inc.
K200011	01/02/2020	E-CLASS« DUAL MOBILITY INSERTS and DYNASTY« DUAL MOBILITY LINERS	Microport Orthopedics, Inc.
K171181	04/24/2017	PROCOTYL« PRIME E-CLASSÖ XLPE Liner	MicroPort Orthopedics, Inc.
K152631	09/15/2015	MPO Total Knee Systems MR Labeling	MICROPORT ORTHOPEDICS, INC.