Ortoma AB receives administrative acceptance review from FDA for Ortoma Treatment Solution™

Publicerat 12 Sep, 2017

FDA writes “An administrative acceptance review was conducted on your premarket notification (510(k)) K172515/S002, and it was found to contain all of the necessary elements and information needed to proceed with the substantive review.”

"- It is an extensive work with the FDA application that now enters its final phase. An approval from FDA opens the big American market for Ortoma, says CEO Matts Andersson."

For further information, please contact:

Prof. Gunnar Németh, MD, PhD, Chairman of the Board
Mobile: +46 70-529 20 00
e-mail: [email protected]

About Ortoma AB (publ)

Ortoma AB develops systems for planning and positioning of implants such as hip, knee and spine implants. Ortoma Treatment Solution™ (OTS) provides a 3D planning module for optimal positioning of the joint implant before surgery and a guide module that during surgery guides the surgeon in real time to the planned optimal position. OTS fits in to existing routines at the OR and there is no bulky hardware in the OP room. OTS aims to improve hospital efficiency and patient quality through decreased frequency of early post-operative dislocations and a possible better long term survival of the implant. Ortoma AB has more than 1.400 shareholders and is listed at Aktietorget.

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.