Medical Device Manufacturer · US , Arlington , TN

Microport Orthopedics, Inc.

37 submissions · 37 cleared · Since 2014
37
Total
37
Cleared
0
Denied

Microport Orthopedics, Inc. — FDA 510(k) Submissions

Microport Orthopedics, Inc. has submitted 37 FDA 510(k) premarket notifications since 2014, of which 37 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented, Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer, Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented, Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer . Use the specialty filter in the sidebar to narrow results.

37 devices
1–25 of 37
NEXUS? Hip Stem
K250444 · LZO Prosthesis, Hip,... · Orthopedic
May 2025 90d
Evolution? Total Knee Systems - Kinematic Alignment Instrumentation and Technique
K243574 · JWH Prosthesis, Knee,... · Orthopedic
Feb 2025 91d
Ceramic Femoral Head
K240452 · LZO Prosthesis, Hip,... · Orthopedic
Apr 2024 57d
EVOLUTION? Hinge Knee System;GUARDIAN? limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS? Limb Salvage System;EVOLUTION? MP Total Knee System; EVOLUTION? MP Total Knee System; EVOLUTION? MP Adaptive CS Insert; EVOLUTION? MP Adaptive PS Tibial Insert; EVOLUTION? MP CS/CR Porous Femur/EVOLUTION? Adaptive CS and PS Inserts; EVOLUTION? Revision CCK System; ADVANCE? Double High Insert; ADVANCE? A-CLASS? Tibial Insert; ADVANCE? Knee System; ADVANCE? Ultra-Congruent Tibial Inse
K240043 · KRO Prosthesis, Knee,... · Orthopedic
Apr 2024 87d
EVOLUTION? Tibial Cones
K233507 · MBH Prosthesis, Knee,... · Orthopedic
Jan 2024 79d
EVOLUTION? Cement Keel
K231947 · JWH Prosthesis, Knee,... · Orthopedic
Oct 2023 123d
EVOLUTION? Hinge Knee System
K230563 · KRO Prosthesis, Knee,... · Orthopedic
Sep 2023 210d
MPO Hip Instruments
K213816 · JDI Prosthesis, Hip,... · Orthopedic
Jan 2022 29d
MPO Knee Instruments; MPO PROPHECY Knee Instruments
K213817 · MBH Prosthesis, Knee,... · Orthopedic
Jan 2022 29d
E-CLASS? DUAL MOBILITY INSERTS and DYNASTY? DUAL MOBILITY LINERS
K200011 · LPH Prosthesis, Hip,... · Orthopedic
Oct 2021 638d
Prime BIOFOAM? Multi-Hole Shells
K201157 · MBL Prosthesis, Hip,... · Orthopedic
Aug 2021 481d
Prime and DYNASTY? Additive Manufacturing Shells
K202705 · OQG Hip Prosthesis,... · Orthopedic
Aug 2021 338d
PROFEMUR? GLADIATOR? Cemented Classic Stem
K201519 · JDI Prosthesis, Hip,... · Orthopedic
Dec 2020 185d
PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar
K200007 · LZO Prosthesis, Hip,... · Orthopedic
Apr 2020 114d
PROFEMUR TL2 Stems
K191632 · LZO Prosthesis, Hip,... · Orthopedic
Oct 2019 110d
MicroPort CoCr Femoral Heads
K190123 · LPH Prosthesis, Hip,... · Orthopedic
Jul 2019 171d
EVOLUTION Stemmed CS Femur
K182125 · JWH Prosthesis, Knee,... · Orthopedic
Dec 2018 122d
Prime E-CLASS XLPE Liner
K181598 · LZO Prosthesis, Hip,... · Orthopedic
Sep 2018 88d
Prime Acetabular Cup System
K180798 · LPH Prosthesis, Hip,... · Orthopedic
Jul 2018 104d
BIOLOX delta Option and Extra-long Heads
K173776 · LZO Prosthesis, Hip,... · Orthopedic
Jul 2018 206d
EVOLUTION? Knee Systems ? MR Labeling, EVOLUTION? BIOFOAM? Tibial System, EVOLUTION? Revision Tibial System, EVOLUTION? Revision CCK System
K180317 · MBH Prosthesis, Knee,... · Orthopedic
May 2018 88d
PROCOTYL? PRIME E-CLASS? XLPE Liner
K171181 · LZO Prosthesis, Hip,... · Orthopedic
Aug 2017 126d
EVOLUTION Revision CCK System
K171389 · JWH Prosthesis, Knee,... · Orthopedic
Aug 2017 89d
PROCOTYL? PRIME Acetabular Cup System
K170444 · LPH Prosthesis, Hip,... · Orthopedic
Jun 2017 132d
BIOFOAM? Additive Manufacturing (BIOFOAM? AM), ADVANCE? BIOFOAM? Tibial Base, EVOLUTION? BIOFOAM? Tibial Base, DYNASTY? BIOFOAM? Acetabular Shell
K170288 · MBH Prosthesis, Knee,... · Orthopedic
Jun 2017 136d
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