Identity
- Trade Name
- SUPARTZ FX FDA PMA
- Generic Name
- Acid, hyaluronic, intraarticular FDA PMA
Identifiers
- PMA Number
- P980044 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
Supartz is a hyaluronic acid intraarticular 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 supplied as a sterile, single-use product for intraarticular administration.
The device is manufactured by Seikagaku Corp. and received FDA PMA approval (P980044) on January 24, 2001. It is intended for use in device class 3 and is indicated specifically for intraarticular use in the knee joint for osteoarthritis pain management.
Frequently asked questions
What is Supartz indicated for?
Supartz 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 Supartz a single-use or reusable device?
Supartz is supplied as a sterile, single-use product for intraarticular injection, meaning it is intended for one-time use only and should not be reused.
What regulatory pathway was used for Supartz approval?
Supartz received approval through the FDA Premarket Approval (PMA) pathway, with PMA number P980044, and was granted approval on January 24, 2001.
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 | P980044 | Class III | Active |
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Manufacturer
- Manufacturer
- Seikagaku Corp.
Sources (1)
- FDA PMA P980044 24 fields · synced Sep 18, 2026