A global healthcare company dedicated to improving lives through innovative orthopedic medical devices.
ORTOBRAND INTERNATIONAL was born from the understanding that a medical device is not just a product, but rather a chance for a patient to return to a normal life.
We are a Romanian multinational company involved in research and development, production, marketing and sales of innovative hyaluronic acid (HA)-based orthopedic medical devices for patients suffering from osteoarthritis.
Our team's goal is to reach and help more and more people, by establishing partnerships with specialized companies around the world.
"A medical device is not just a product, but rather a chance to return to a normal life.
The basis of every ORTHOFLEX product®.
In 1934, Karl Meyer first announced the discovery of hyaluronic acid — a natural glycosaminoglycan found in all animal tissues and fluids. Dr. Endre A. Balazs later demonstrated that HA injections into arthritic knees can reduce inflammation and pain — inspiring our mission.
All ORTHOFLEX® products use HA produced through biofermentation — a bacterial fermentation process that produces high-quality hyaluronic acid, free of animal sources, on an industrial scale. This eliminates any risk of allergic reactions and ensures a consistent molecular weight.
The ORTHOFLEX one® and gel® products use proprietary cross-linking technology — bonding the HA chains with chondroitin sulfate to create a more durable, long-lasting viscoelastic network. This increases biocompatibility and delays cartilage degeneration.
All manufacturing complies with Good Manufacturing Practice (GMP) and the European Medical Device Directive. The products are accredited by NSAI and certified CE, ISO 13485 as Class III medical devices.
All ORTHOFLEX® products bear the CE marking, confirming compliance with the European Medical Device Directive (93/42/EEC) and permission to be placed on the European market.
Our quality management system is certified to ISO 13485 — the international standard specific to medical device manufacturers — ensuring consistent design, development and manufacturing processes.
Manufacturing fully complies with GMP guidelines, ensuring that every batch of ORTHOFLEX® products meets rigorous safety, quality and efficacy standards through controlled manufacturing processes.
ORTHOFLEX® products are classified as Class III medical devices — the highest-risk category — confirming that they meet the strictest safety requirements for injectable devices.
Explore our ORTHOFLEX® product line or get in touch with our team.