Identity
- Trade Name
- DUROLANE FDA PMA
- Generic Name
- Acid, hyaluronic, intraarticular FDA PMA
Identifiers
- PMA Number
- P170007 FDA PMA
- FDA Product Code
- MOZ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Orthopedic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
Durolane is a hyaluronic acid intraarticular injection designed for the treatment of pain associated with osteoarthritis of the knee. It is indicated for use in patients who have not responded adequately to conservative non-pharmacological therapy or simple analgesics such as acetaminophen.
This device is manufactured by Bioventus LLC and has received FDA PMA approval. It is intended for clinical application in patients meeting the specified criteria for osteoarthritis pain management.
Frequently asked questions
What is Durolane used for?
Durolane is indicated for the treatment of pain in patients suffering from osteoarthritis of the knee who have not found sufficient relief through conservative non-pharmacological treatments or simple analgesics.
What type of product is Durolane?
Durolane is an intraarticular hyaluronic acid injection, classified as a medical device for orthopedic use.
Who manufactures Durolane?
Durolane is manufactured by Bioventus LLC, based in Durham, North Carolina.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Joint Therapies - Bioventus, Bioventus Launches Company in the UK, Ireland, Sweden ..., Bioventus Agrees to Nationwide Contract with ..., BIOVENTUS LLC DUROLANE (HYALURONIC ACID) INJECTION, DUROLANE - Bioventus OA Knee Pain Relief
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Active |
| FDA PMA | United States | FDA_PMA | P170007 | Class III | Active |
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Manufacturer
- Manufacturer
- Bioventus Llc
- FDA Applicant
- Bioventus, LLC
Sources (2)
- FDA PMA P170007 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026