{"publicDeviceRecordKey":"9e0becba-835a-4a7a-b267-018b5ca2802d","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2025-11-19T00:00:00.000Z","devicePublishDate":"2015-08-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"03596010598103","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"R3","versionModelNumber":"71334948","catalogNumber":"71334948","dunsNumber":"045483575","companyName":"Smith \u0026 Nephew, Inc.","deviceCount":1,"deviceDescription":"R3 20 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 48MM","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)238-7538","phoneExtension":null,"email":"GUDID@SMITH-NEPHEW.COM"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K113848","supplementNumber":"000"},{"submissionNumber":"K211176","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"43168","gmdnPTName":"Non-constrained polyethylene acetabular liner","gmdnPTDefinition":"A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JDI","productCodeName":"Prosthesis, hip, semi-constrained, metal/polymer, cemented"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Angle","size":{"unit":"degree","value":"20"},"sizeText":null,"sizeString":"Angle: 20 degree"}]},"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}