Identity
- Trade Name
- TRILURON FDA PMA
- Generic Name
- Acid, hyaluronic, intraarticular FDA PMA
Identifiers
- PMA Number
- P180040 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
TRILURON is an intraarticular hyaluronic acid injection indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics such as acetaminophen. It is a sterile, single-use product supplied in pre-filled syringes for injection into the knee joint.
TRILURON is manufactured by Fidia Farmaceutici S.p.A. and is supplied as a sterile, single-use device. It is intended for use in clinical settings by qualified healthcare professionals. The device has received FDA PMA approval (P180040) and is classified as a Class III medical device under the generic name Acid, hyaluronic, intraarticular.
Frequently asked questions
What is TRILURON used for?
TRILURON is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics such as acetaminophen, as stated in the approval documentation.
Is TRILURON a single-use or reusable device?
TRILURON is supplied as a sterile, single-use device in pre-filled syringes, intended for one-time injection into the knee joint and not designed for reuse.
Who manufactures TRILURON and what is its FDA authorization?
TRILURON is manufactured by Fidia Farmaceutici S.p.A. and has received FDA Premarket Approval (PMA) under application number P180040.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P180040 | Class III | Active |
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Manufacturer
- Manufacturer
- Fidia Farmaceutici S.p.A.
Sources (1)
- FDA PMA P180040 24 fields · synced Sep 18, 2026