{"publicDeviceRecordKey":"91128913-a0eb-4e94-af54-f9cd3c14c1d4","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2023-01-25T00:00:00.000Z","devicePublishDate":"2016-01-12T00:00:00.000Z","deviceCommDistributionEndDate":"2026-12-31T00:00:00.000Z","deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M268102095481","deviceIdType":"Secondary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"10381780238317","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Cadence™","versionModelNumber":"10209548","catalogNumber":"10209548","dunsNumber":"942377524","companyName":"Ascension Orthopedics, Inc.","deviceCount":1,"deviceDescription":"The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidly fixed to the Tibial Tray intra-operatively. In conjunction with the Talar Dome and Tibial Tray, the system is intended for both primary surgery and revision surgery applications which are designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. These components are available in a variety of sizes and design configurations.","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":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)654-2873","phoneExtension":null,"email":"custsvcnj@integralife.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K151459","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"33718","gmdnPTName":"Fixed-bearing total ankle prosthesis","gmdnPTDefinition":"A sterile implantable artificial substitute for an ankle joint designed to replace the main articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes tibial and talar components typically with parts made of metal and polyethylene (PE); the PE bearing that articulates the two components is attached or moulded to one of the components. Fixation devices (e.g., screws) for implantation may be included and implantation may be performed with or without bone cement.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HSN","productCodeName":"PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Size 5, Right, 8mm, Posterior Biased"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Store in a clean, dry environment. Protect from sunlight and extreme temperatures."}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}