← Back to catalogue

Monovisc Injectable Intra-Articular Device

FDA PMA

Class III (US FDA PMA)

PMA P090031

by Anika Therapeutics, Inc.

Identity

Trade Name
MONOVISC FDA PMA
Generic Name
Acid, hyaluronic, intraarticular FDA PMA

Identifiers

PMA Number
P090031 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

The Monovisc Injectable Intra-Articular Device is a hyaluronic acid-based viscosupplement classified as an intraarticular acid. It is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have not responded adequately to conservative non-pharmacologic therapy and simple analgesics.

This device is supplied as a single-use, sterile injectable solution for intra-articular administration. It is intended for use in clinical settings by healthcare professionals and has received FDA PMA approval under PMA number P090031. The device is available in a 4ml formulation containing 88mg of hyaluronic acid, with multiple registration numbers for tracking and distribution.

Frequently asked questions

What is the Monovisc Injectable Intra-Articular Device used for?

The Monovisc device is a hyaluronic acid-based viscosupplement indicated for treating pain in osteoarthritis of the knee in patients who have not responded adequately to conservative non-pharmacologic therapy and simple analgesics.

How is the Monovisc device supplied and administered?

The device is supplied as a single-use, sterile injectable solution for intra-articular administration. It comes in a 4ml formulation containing 88mg of hyaluronic acid and is intended for use in clinical settings by healthcare professionals.

Is the Monovisc device reusable or single-use only?

The Monovisc device is supplied as a single-use product, meaning it should only be used for one patient administration and then discarded appropriately.

What is the regulatory status of the Monovisc device?

The Monovisc device has received FDA PMA approval under PMA number P090031, which indicates it has undergone a rigorous pre-market approval process for safety and effectiveness.

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: Monovisc OA Knee Pain Injection | Anika, Monovisc 88mg/4ml kaufen – Anika Therapeutics HA ... - Novamedo

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Anika Therapeutics, Inc.

Sources (1)

  • FDA PMA P090031 24 fields · synced Sep 18, 2026