cb15eebc-2e14-428c-9999-818339c05547NewPublished12023-10-052023-09-272028-09-27In Commercial DistributionM684PNV109131SecondaryHIBCC00192629405486PrimaryGS1ProphecyPNV10913PNV10913079118736Microport Orthopedics Inc.1PROPHECY® ALIGNMENT GUIDESfalsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(866)872-0211Stephen.Weaver@ortho.microport.com60826Custom-made orthopaedic/craniofacial surgical guideA custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is made of synthetic polymer materials and is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.falseActiveMBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMERJWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMERfalsetrueMoist Heat or Steam Sterilization