58b0ce28-bbe6-4e3a-9eca-66d6e70555b3NewPublished12026-05-132026-05-05In Commercial DistributionTKRL0001D2DB0PrimaryHIBCCPointCloud Knee InstrumentsUKI0201-L118205691Unik Orthopedics Inc.1UNIKO PointCloud Knee Instrument KitfalsefalsefalsefalsefalsetruefalsetruetruetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse58910Total knee prosthesis implantation guide-instrument kitA collection of sterile hand-held surgical instruments intended to be used during total knee arthroplasty (TKA), either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. Components may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components; the implant is not included. This is a single-use device.falseActiveOOGKnee Arthroplasty Implantation SystemMBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerJWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerLLZSystem, Image Processing, RadiologicalfalsetrueMoist Heat or Steam Sterilization