Medyssey, a leading specialist in spinal and orthopedic implants, has ramped up its efforts to penetrate the U.S. spinal implant market by securing three U.S. Food and Drug Administration (FDA) 510(k) certifications this year.
The company announced on Tuesday that its Odys-SI Screw, an implant designed to stabilize the sacroiliac joint where the spine meets the pelvis, has received FDA 510(k) certification. This marks Medyssey’s third certification in 2023, following approvals for the Neptune 3D SA cervical cage in June and the Neptune SA cervical cage in September.
The Odys-SI Screw is a surgical solution for patients suffering from pain or reduced functionality due to sacroiliac joint issues. Its primary function is to stabilize the joint, promoting bone fusion.
Manufactured using 3D printing technology with medical-grade titanium alloy, the screw boasts a roughened surface to maximize bone contact. It also features a cavity for bone graft material and comes in various sizes to accommodate different patient needs.
The expansion into the U.S. market is bolstered by promising global growth projections. Market research firm Technavio forecasts that the global spinal implant market will grow at a compound annual rate of 5.3% from 2025 to 2029, potentially adding 3.55 billion USD to the market size. North America is expected to drive about 43% of this growth during the period.
Leveraging its recent FDA certifications, Medyssey aims to diversify its product range in the U.S. market and expand applications of its 3D printing technology.
Medyssey Chief Executive Officer (CEO) Sung Kyung-soo said that this year’s trio of FDA 510(k) certifications underscores our robust product development capabilities and technological edge. It’s committed to enhancing the global competitiveness, particularly in the U.S. market, by leveraging the expertise in 3D printing and product innovation.
As a pioneer in patient-specific implants, Medyssey was the first South Korean company to adopt metal 3D printing equipment. The firm supplies both spinal implants and 3D-printed customized implants domestically and internationally, with a growing global presence through subsidiaries and distribution networks in the U.S., Chile, and Thailand.
Medyssey’s roots trace back to 2003 when it was established as Verian, a medical device manufacturer and distributor. The company rebranded as Medyssey in 2007 and set up a corporate research institute, pivoting towards specialization in spinal implants. It entered the global market in 2009 after securing FDA 510(k) approval for its spinal implant products. In a groundbreaking move, Medyssey became South Korea’s first adopter of metal 3D printing technology for customized implant development in 2011.