ae5faf44-9224-4441-b07a-9c251c53a3e0NewPublished12021-05-102021-04-30In Commercial DistributionM5726556C012011PrimaryHIBCCTriathlon AS-1 PS Box Ream Cementless Instrumentation Kit 6556C012016556-C-012808821883Conformis, Inc.1Triathlon AS-1 PS Surgical Instruments, Cementless, PS insert, box ream, sizes 0-8, Right and LeftfalsefalsefalsetruefalsetruefalsetruefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse781-345-9001customer-service@conformis.comK20342100058910Total 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 SystemJWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDevice Size Text, specifyFemur prep size 0 to size 8; tibial prep size 0 to size 8truefalse