638b1326-921c-409c-84df-b6b3d793acd7UpdatePublished32023-05-032016-09-24In Commercial Distribution07613327231885PrimaryGS1INSTRUMENT6633-9-8706633-9-870058311945Howmedica Osteonics Corp.1IM REVISION TIBIAL CUTTING GUIDE DURACON MONOGRAM KNEEfalsetruefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse13180Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.falseActiveLXHORTHOPEDIC MANUAL SURGICAL INSTRUMENTDevice Size Text, specifyDegree: 12.0 DegreefalsetrueMoist Heat or Steam Sterilization