Ortoma Submits US FDA 510(k) Application for Spine Module

Publicerat 28 May, 2021

Ortoma has submitted a regulatory application for FDA 510(k) clearance of its spine module to be included in the platform Ortoma Treatment Solution (OTS). The spine module is a pre-operative planning solution for spine surgery. The OTS platform is a surgical system that is assisted by AI (Artificial Intelligence) for improved accuracy, efficiency and surgical outcome.


The submission has been accepted for review by the US FDA (US Food & Drug Administration). The result of the review is expected during the 2[nd] half-year 2021. After receiving FDA 510(k) clearance, the product will be available for use clinically in USA. The product has CE-mark for marketing on the European market since before.

"USA is the single largest market for spine surgery, followed by Europe. With clearance by the FDA in addition to the CE-mark for Europe, we will reach more than 75% of the global spine surgery market" says Linus Byström, CEO of Ortoma.

An FDA 510(k) cleared spine module significantly extends the market potential of OTS. The global spine surgery market is estimated to reach $14.3 billion in 2022 from $10.8 billion in 2017, at a CAGR of 5.8%. Factors driving the growth of the industry include growing incidence of spinal disorders, accessibility of minimally invasive spine surgical techniques, and the increase of Minimally Invasive Spine Surgery in health care centers. The spine module is built on the OTS platform that is assisted by AI and is designed to address the challenges of the spine surgery market.


Ortoma – Improved Performance

About Ortoma AB (publ)
Ortoma AB develops surgical systems for the planning and positioning of implants in hip, knee and spinal surgery. The purpose of the company’s surgical system, Ortoma Treatment Solution™ (OTS) is to enable surgeons to accurately measure and plan 3D surgery for the placement of joint implants, and during surgery, to optimally position the implant in the patient. Ortoma’s surgical system is aimed at providing better patient outcomes, fewer complications and less follow-up surgeries – and thus better long-term survival rates for implants. OTS is a system that is easily integrated into the processes and routines currently used in surgery, thereby increasing efficiency. Globally, more than 7.5 million orthopedic procedures are performed each year where OTS could be used in hip, knee and spinal surgery. In Sweden, around 42,000 surgical procedures were performed last year, involving hip, knee or spinal surgery. Ortoma’s B shares are listed on Spotlight Stock Market.