FDA applicant
Microport Orthopedics, Inc.
FDA records 42 decisions for Microport Orthopedics, Inc. (Arlington, TN) from 2003 to 2026: 40 510(k) clearances and 2 original PMA approvals. Most are in product codes LZO (Prosthesis, Hip, Semi-Constrained…) and MBH (Prosthesis, Knee, Patello/Femorotibial…). Since 2016 its 510(k)s took a median of 110 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 170 predicates, 56 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Microport Orthopedics”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Microport Orthopedics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Microport Orthopedics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Microport”
FDA records each applicant name separately; these may or may not be the same firm.