About 3D Plasty
3D Plastyspecialises in the production of 3D printed bioresorbable implants that are used in conjunction with surgical procedures to assist with the natural stages of bone healing. 3D Plasty's products are manufactured in-house using 3D printing technology that is precise and allows for customisation of shape and geometry.
The unique 3D printed biomimetic micro architecture of the 3D scaffolding which is contained within the 3D Plastyproducts provides for infiltration of cells and blood vessels, both of which play key roles in wound healing and tissue repair. 3D Plastyproducts are made of a US FDA approved polymer called polycaprolactone (PCL). PCL is bioresorbable, malleable, slow-degrading and possesses mechanical strength similar to trabecular bone.
History of Development
3D Plasty platform technology started development in 1996, acquiring extensive engineering and clinical experience.
US FDA GMP Inspection - Feb 2019
Successful inspection by US FDA inspector at our JTC MedTech Hub manufacturing facility
3D Plasty Manufacturing Process - 2018
Upgraded to ISO 13485 Medical Device Regulation
3D Plasty Manufacturing Process - 2016
Achieved the Korea GMP in 2016
CE Mark Approval - 2009
CE Mark Approval for Osteoplug™ for burr hole cover, and Osteomesh™ for orbital floor reconstruction
3D Plasty Manufacturing Process - 2007
Achieved the ISO 13485 certification