Microport Orthopedics, Inc.: FDA filings under this applicant name
FDA lists 39 510(k) clearances under 2 spellings of the applicant name “Microport Orthopedics, Inc.” (first 2014, latest 2026), plus 2 PMA decisions, across 11 product codes in 1 review panel. Median 510(k) review time under this name: 110 days. Since 2017 the median was 118 days, against 101 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 5 | 85 |
| 2015 | 5 | 89 |
| 2016 | 1 | 190 |
| 2017 | 5 | 132 |
| 2018 | 5 | 104 |
| 2019 | 2 | 140 |
| 2020 | 2 | 150 |
| 2021 | 3 | 481 |
| 2022 | 2 | 29 |
| 2023 | 2 | 166 |
| 2024 | 4 | 83 |
| 2025 | 2 | 90 |
| 2026 | 1 | 270 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Microport Orthopedics, Inc. took a median 118 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 12 | 12 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 8 | 8 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 6 | 6 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 6 | 6 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 | 2 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 2 | 2 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | 1 | 1 |
| MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | 1 | 0 |
| NXT | Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing | 1 | 0 |
Plus 1 more product codes.
Review panels
- Orthopedic (41)
Most recent Microport Orthopedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253728 | EVOLUTION® AM BIOFOAM® Tibial System | MBH | 2026-08-21 | 270 |
| K250444 | NEXUS® Hip Stem | LZO | 2025-05-15 | 90 |
| K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | JWH | 2025-02-18 | 91 |
| K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips | LPH | 2024-04-18 | 101 |
| K240452 | Ceramic Femoral Head | LZO | 2024-04-12 | 57 |
| K240043 | 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 | KRO | 2024-04-01 | 87 |
| K233507 | EVOLUTION® Tibial Cones | MBH | 2024-01-18 | 79 |
| K231947 | EVOLUTION® Cement Keel | JWH | 2023-10-31 | 123 |
| K230563 | EVOLUTION® Hinge Knee System | KRO | 2023-09-27 | 210 |
| K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | MBH | 2022-01-05 | 29 |
29 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P030042 | PMA | CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM | 2009-11-03 |
| P030027 | PMA | CERAMIC TRANSCEND HIP ARTICULATION | 2003-07-07 |
Recalls
33 product recalls in 15 recall events; 6 initiated in the last five years. Most recent: 2025-12-19.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Microport Orthopedics, Inc. is the lead sponsor of 18 device studies on ClinicalTrials.gov (15 active or recruiting). Most recent:
- NCT07391592: Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert (Active not recruiting, started 2025-08-18)
- NCT06142669: EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol (Recruiting, started 2023-10-31)
- NCT04816773: Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert (Enrolling by invitation, started 2022-01-27)
- NCT04147559: Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem (Enrolling by invitation, started 2020-10-21)
- NCT04145401: Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK (Enrolling by invitation, started 2020-09-30)
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Microport Orthopedics, Inc. (40)
- Microport Orthopedics (1)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- MicroPort NeuroTech (Shanghai) Co., Ltd. (4 510(k)s)
- Microport Navibot International, LLC (1 510(k)s)
- Microport Orthopedics Inc. (Mpo) (1 510(k)s)
- MicroPort CRM USA, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Microport Orthopedics, Inc.?
FDA lists 39 510(k) clearances under 2 spellings of the applicant name “Microport Orthopedics, Inc.” (first 2014, latest 2026), plus 2 PMA decisions, across 11 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Microport Orthopedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microport Orthopedics, Inc. is 110 days. Since 2017: 118 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Microport Orthopedics, Inc.?
The most frequent FDA product codes under this applicant name are LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 12); MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, 8); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 6).
Next steps
- See all 39 Microport Orthopedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LZO, Microport Orthopedics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.