e4d9d9d8-19b3-46b8-b1ea-17f459a65409UpdatePublished22025-04-112024-11-12In Commercial Distribution09348215111663PrimaryGS1Rx Knee AP Symmetrical Augment Size 4 - 8mm Titanium Half Draft Right121-20-9284751993028SIGNATURE ORTHOPAEDICS PTY LTD1falsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK24068300067099Temporary knee prosthesis, non-customizedA prefabricated, implantable device that includes a pharmaceutical antibiotic agent (e.g., gentamicin) intended to be used as a temporary substitute for a knee prosthesis to: 1) provide a means for limited mobility/weight-bearing; and 2) release the antibiotic agent to the periprosthetic space to treat infection as part of a revision orthopaedic surgery. Also known as a spacer, it may include knee femur and/or tibial components, and is made of metallic and/or polymer materials. Following infection treatment and device explantation, a definitive prosthesis is implanted.trueActiveJWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymertruefalse