Ortoma receives FDA 510 (k) clearance for OTS™ Hip in the US

Published March 13, 2024

Ortoma AB (publ), a trailblazer in the realm of orthopedic technology, announces that it has obtained FDA 510(k) clearance for OTS™ Hip. This approval allows Ortoma to market OTS™ Hip in the United States, the largest market worldwide for orthopedic surgical equipment. The OTS™ platform is a surgical system powered by AI, enhancing precision, efficiency, and surgical outcomes.

Linus Byström, commented, “This marks a critical milestone for Ortoma in commercializing OTS™ Hip in the vast U.S. market. The regulatory clearances we pursue are pivotal for our market position and we are looking forward to bring our solution to the US.”

The OTS™ Hip system in its latest version incorporates cutting edge technology with advanced machine learning algorithms. This version has now received FDA 510(k) clearance, which serves as a cornerstone for the launch of OTS™ Hip in the U.S. market.

About OTS™
Ortoma Treatment Solution (OTS™) is a product used for orthopedic procedures, specifically for hip surgery, that includes OTS™ Hip Plan and OTS™ Hip Guide for preoperative planning, intraoperative navigation, and postoperative follow-up of hip implant surgery. The system’s software, which is based on artificial intelligence, enables improved accuracy, efficiency, and surgical results.

Ortoma – Improved Performance
For additional information, please contact:
Ortoma CEO Linus Byström
e-post: [email protected]

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 Nasdaq First North Growth Market Stockholm.