HS Code for Orthopedic Implants
The HS Code for orthopedic implants is 902110. The MFN duty rate for importing to the US is Free.
| HS Code (6-digit) | 902110 |
|---|---|
| US Duty Rate (MFN) | Free |
| EU Duty Rate (MFN) | 0% |
| Chapter | 90 |
| Heading | 9021 |
| Last Updated | 2026-05 |
Description
Orthopaedic or fracture appliances
HS Code 902110 covers orthopedic or fracture appliances, including implants, with a US MFN duty rate of Free.
Frequently Asked Questions
What specific customs risks are associated with importing orthopedic implants under HTS 902110?
Orthopedic implants under HTS 902110 face high scrutiny for FDA Premarket Approval (PMA) or 510(k) clearance documentation. Customs may detain shipments if the FDA registration of the foreign manufacturer, device listing, and proof of compliance with Quality System Regulations (21 CFR Part 820) are not readily available. Physical inspection for sterility and proper labeling is also common, which can delay clearance.
What are the primary additional costs, beyond the product price, when importing orthopedic implants under HTS 902110?
Importers typically incur a 2.6% U.S. Most-Favored-Nation (MFN) duty rate for this HTS code, plus a Merchandise Processing Fee (MPF) of 0.3464% of the entered value (minimum $27.23, maximum $614.35). Furthermore, these medical devices are subject to FDA user fees, including a $6,493 FY 2024 Medical Device Establishment Registration fee for the foreign manufacturer, which is often passed through to the importer.
Medical Device Compliance for Orthopedic Implants
Orthopedic implants under 9021.10 are Class II or III medical devices and require U.S. FDA 510(k) clearance or Premarket Approval (PMA). Importers must provide the FDA Establishment Identifier (FEI) number and ensure products are listed with the FDA. Shipments typically require a FDA Form 3514. Additionally, many implants must comply with the FDA's Unique Device Identification (UDI) system for traceability (21 CFR Part 830). Country-of-origin marking must be permanent and visible on the device or its sterile packaging per 19 CFR 134.
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