{"publicDeviceRecordKey":"cc9c6f2c-e22c-4496-98ce-dd4fb3aca79f","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2025-05-30T00:00:00.000Z","devicePublishDate":"2015-10-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00880304440586","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Vanguard® SSK Knee System","versionModelNumber":"185010","catalogNumber":"185010","dunsNumber":"129278169","companyName":"Biomet Orthopedics, LLC","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)348-9500","phoneExtension":null,"email":"customerservice@zimmerbiomet.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K042757","supplementNumber":"000"},{"submissionNumber":"K171054","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"33665","gmdnPTName":"Posterior-stabilized total knee prosthesis","gmdnPTDefinition":"A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the damaged/degenerative joint [total knee arthroplasty (TKA)] or for prosthesis revision; it is implanted when the posterior cruciate ligament is sacrificed and uses a “cam and post” mechanism to replace the stabilizing function of the ligament. It includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implanted with or without bone cement and is often used in cases where bone stock and mediolateral stability are good in the face of severe deformities or ligament degeneration.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JWH","productCodeName":"PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER"},{"productCode":"MBV","productCodeName":"Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer"},{"productCode":"HRY","productCodeName":"PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER"},{"productCode":"OIY","productCodeName":"Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive"},{"productCode":"MBH","productCodeName":"PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"20 mm 59 mm Small Post"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}