Orthopedics company Small Bone Innovations' (SBi) facilities in Morrisville, PA and Péronnas, France have received manufacturers' accreditation from the government of Japan.
Japan’s Ministry of Health, Labor and Welfare issued the accreditation certification in the ‘General Manufacturing’ category for orthopedic products.
The accreditation will allow product registrations in Japan for orthopedic technologies at $25bn in revenues annually.
The application included a full review of SBi’s current manufacturing standards and practices and the ability of the partnership with Olympus Terumo Biomaterials (OTB) to deliver products throughout Japan in compliance with all relevant regulations.
The award is an important step in strengthening SBi’s strategic partnership with Olympus Terumo Biomaterials (OTB), Tokyo, to exclusively market an extensive portfolio of small bone & joint implants and instrumentation in Japan, including SBi’s flagship product, the STAR Total Ankle Replacement System.
SBi chairman and CEO Anthony Viscogliosi said by joining with both Olympus and its subsidiary Olympus Biotech they are gaining a foothold in one of the world’s sophisticated orthopedics markets and advancing their growth potential in Asia Pacific.