c51c8a4e-b501-4550-bd8e-1e12c8f8fc50UpdatePublished32023-05-032018-12-17In Commercial DistributionB1132N1IV000000PrimaryHIBCCShoulder Innovations Humeral Short Stem SystemVersion Control2N1IV00000080404519Shoulder Innovations, Inc.1Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Version Control. falsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse616-294-1026xxx@xx.xxK102670000K110905000K111596000K17382400013180Orthopaedic 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.falseActiveMBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedHSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedKWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedKWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedfalsetrueMoist Heat or Steam Sterilization