1bd6f255-6552-4494-a333-007ee28f9043UpdatePublished32023-05-032017-08-07In Commercial Distribution00888912129985PrimaryGS1DJO SURGICAL801-01-441154074504Encore Medical, L.P.1TRIAL, CURVED INSERT, PRIMARY, SIZE10 11MMfalsefalsefalsefalsefalsefalsetruefalsetruetruefalsefalsefalseLabeling 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.falseActiveFZXGuide, Surgical, InstrumentfalsetrueMoist Heat or Steam Sterilization