Hymovis High Molecular Weight Viscoelastic Hyaluronan
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- HYMOVIS FDA PMA
- Generic Name
- Acid, hyaluronic, intraarticular FDA PMA
Identifiers
- PMA Number
- P150010 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
Hymovis is an intraarticular acid hyaluronic device classified as a Class III medical product. It is formulated as a high molecular weight viscoelastic hyaluronan designed to restore synovial fluid properties in osteoarthritic joints, providing lubrication and cushioning to alleviate joint pain and improve mobility.
The device is supplied as a sterile, single-use injectable solution intended for intraarticular administration in patients with knee osteoarthritis unresponsive to conservative therapies. It is regulated under FDA PMA approval (P150010) and distributed in pre-filled syringes, requiring refrigeration prior to use. Compliance with FDA guidelines ensures its safety and efficacy for intraarticular use, with no MRI safety restrictions specified.
Frequently asked questions
What is Hymovis designed to help with in patients who haven’t responded well to basic treatments for knee osteoarthritis?
Hymovis is formulated as a high molecular weight viscoelastic hyaluronan intended to restore synovial fluid properties in osteoarthritic knees. It provides lubrication and cushioning to reduce pain and improve mobility for patients whose symptoms persist despite conservative therapies like physical activity, weight management, or simple analgesics such as acetaminophen.
How is Hymovis supplied, and what storage conditions are required before use?
Hymovis comes as a sterile, single-use injectable solution in pre-filled syringes, designed for direct intraarticular administration. It must be stored under refrigeration prior to use to maintain its integrity and efficacy.
Can Hymovis be reused, or is it intended for one-time use per patient?
Hymovis is explicitly labeled as a single-use device, meaning each pre-filled syringe is intended for one intraarticular injection per patient. Reuse is not recommended or supported by the manufacturer.
Are there any MRI safety restrictions for patients who receive Hymovis?
The device documentation does not specify any MRI safety restrictions for Hymovis, meaning it does not contain components or materials that would typically contraindicate MRI scans post-administration.
What regulatory pathway does Hymovis follow, and how does that affect its availability?
Hymovis follows the FDA Premarket Approval (PMA) pathway, indicated by the PMA number (P150010). This approval ensures its safety and effectiveness for the specified use in treating knee osteoarthritis pain when conservative therapies fail, confirming its authorized distribution in the U.S. market.
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 | P150010 | Class III | Active |
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Manufacturer
- Manufacturer
- Fidia Farmaceutici
Sources (1)
- FDA PMA P150010 24 fields · synced Sep 18, 2026