Device typeOrthopaedic prosthesis implantation positioning instrument, reusable: A 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.
FDA categoryProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented, Prosthesis, hip, semi-constrained, metal/polymer, cemented, PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Device ID04026575397471
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information