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Orthovisc High Molecular Weight Hyaluronan

FDA PMA

Class III (US FDA PMA)

PMA P030019

by Anika Therapeutics, Inc.

Identity

Trade Name
ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN FDA PMA
Generic Name
Acid, hyaluronic, intraarticular FDA PMA

Identifiers

PMA Number
P030019 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

Orthovisc High Molecular Weight Hyaluronan is an intraarticular hyaluronic acid injection classified as an acid, hyaluronic, intraarticular device. It is designed to restore synovial fluid viscosity and lubrication in the knee joint, aiding joint function and pain relief in patients with osteoarthritis.

This device is supplied as a sterile, single-use injectable solution intended for intraarticular administration by a healthcare professional. It is approved under an FDA Premarket Approval (PMA) for use in patients with osteoarthritis of the knee who have not responded adequately to conservative therapies. Storage and handling must comply with sterile injection protocols, and its use is governed by the specified PMA authorization.

Frequently asked questions

What is Orthovisc designed to treat, and who is it intended for?

Orthovisc is an intraarticular hyaluronic acid injection intended to restore synovial fluid viscosity and lubrication in the knee joint. It is specifically approved for patients with osteoarthritis of the knee who have not responded adequately to conservative therapies, such as non-pharmacologic treatments and simple analgesics like acetaminophen.

How is Orthovisc supplied, and is it reusable?

Orthovisc is supplied as a sterile, single-use injectable solution. Due to its sterile nature and classification as a single-use device, it is not intended for reuse after administration.

What regulatory pathway does Orthovisc follow, and what does that mean for its use?

Orthovisc follows the FDA Premarket Approval (PMA) pathway, indicated by the PMA number (P030019). This means its safety and effectiveness have been thoroughly evaluated by the FDA, and its use is governed by the specific approval criteria outlined in the PMA authorization, including its indication for osteoarthritis of the knee.

Are there multiple sizes or models of Orthovisc available?

The provided data lists multiple registration numbers, which typically correspond to different lots or batches rather than distinct sizes or models of the device. Orthovisc is primarily characterized by its high molecular weight hyaluronan formulation, and no specific size or model variations are detailed in the data.

How should Orthovisc be stored, and what precautions should be taken?

Since Orthovisc is a sterile injectable solution, it must be stored and handled according to standard sterile injection protocols. The data does not specify exact storage conditions, but generally, sterile injectables should be kept in a cool, dry place away from direct light until use, and any unused portions should be discarded to maintain sterility.

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

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Anika Therapeutics, Inc.

Sources (1)

  • FDA PMA P030019 24 fields · synced Sep 18, 2026