A high-strength, osteoconductive and bioresorbable material for osteosynthesis.

Teijin Medical Technologies Co., Ltd. compounds Poly-L-Lactide acid (PLLA) and bioactive ceramic microparticles (HA) by proprietary method, and makes manufacturing and marketing with the approvals as OSTEOTRANS-MX which has strength higher than human cotical bone, bioresorption and bioactivity.
OSTEOTRANS has following characteristics similar to former Poly-L-Lactide acid products,

• Degraded and resorbed in vivo; therefore, there is no need for removal surgery, thereby reducing patient burden.
• No risk of corrosion, unlike metals.
• It is safe in vivo.

Although research on this type of composite material has been conducted from several perspectives, none of the previously available materials met the conditions of achieving and keeping the strength higher than that of the human bone for the minimum period of 3-4 months that are required for bone recovery.
OSTEOTRANS is a composite made of PLLA and u-HA particles and is molded using our proprietary methods. It succeeds in providing a composite material that is stronger than human cortical bone, and the strength is maintained for 4 ~ 6 months. Furthermore, it provides a novel function. After implantation, it is integrated with the surrounding bone and return to its original state. This function is not available in conventional absorbable material. The product is manufactured at Yasutomi Factory (Himeji City, Hyogo Prefecture) that has ISO 13485 certification,which is required for quality management systems for medical devices.