Orthopeadics

Hyaluronic Acids
Artosyal M
Orthopaedics

ARTOSYAL is an implantable, intra-articular medical device intended to be injected into the joints as synovial fluid supplementation. ARTOSYAL, thanks to its viscoelastic and lubricant properties, promotes the restoration of rheological conditions of the joints in degenerative or post-traumatic conditions.

This device is composed of sterile, non-pyrogenic, viscoelastic, colourless, translucent gel of linear hyaluronan (HA) molecules in a pH and osmolality balanced aqueous carrier. The product is intended to be slowly resorbed by the body, providing long-term efficacy. In conformity with MDD 93/42/EEC, ARTOSYAL is a Class III device under MDD 93/42, Attachment IX, rule 8, as long-term (> 30 days), surgically-invasive, implantable device: “All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended to have a biological effect or to be wholly or mainly absorbed, in which case they are in Class III”.

The product is supplied in terminally-sterilized (steam), pre-filled glass syringes.
The syringe is equipped with a connector to facilitate the attachment of the needle as well as a custom finger grip and plunger rod.

The finger grip (backstop) is designed to enhance holding of the syringe.
The syringes are placed in a non-sterile, molded rigid PVC tray, which, along with the instructions for use (IFU), is placed in a cardboard carton
The individual members of the ARTOSYAL family, sterile gel intended for the viscoinduction and viscosupplementation of the joints, are listed below.

 

 

 

 

 

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