OOOPDS, the Orthopedic Operation and Object Planning Digital System developed by Taiwan Main Orthopaedic Biotechnology Co., Ltd. (Surglasses), has received 510(k) clearance from the US Food and Drug Administration (FDA). The clearance number is K254214, with a decision date of 15 September 2026, and it can be checked in the FDA 510(k) database. With this clearance, OOOPDS can be marketed in the United States.
Technology related to OOOPDS has also been granted a US invention patent, US 12,558,162 B2, titled Method, system and apparatus for designing a bone plate to be used in an orthopedic surgery and published on 24 February 2026.
In Taiwan, OOOPDS holds a TFDA medical device license, MOHW-MD-No. 007110, valid until 1 April 2031.
OOOPDS turns a patient's own CT or MRI data into a 3D reconstruction that the surgeon can work on before the case: reducing the fracture, planning the screw path and shaping the plate. It loads DICOM images, shows multi-directional 2D cross-sections alongside the 3D view, and exports finished objects as .stl, .ply or .obj files for 3D printing.
To learn more, see the OOOPDS product page, or contact us to arrange a demonstration.