{"publicDeviceRecordKey":"4de5a98a-5882-440b-a781-04d4b754b198","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":11,"publicVersionDate":"2026-03-23T00:00:00.000Z","devicePublishDate":"2017-08-07T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00888912168564","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"DJO SURGICAL","versionModelNumber":"530-18-220","catalogNumber":null,"dunsNumber":"154074504","companyName":"Encore Medical, L.P.","deviceCount":1,"deviceDescription":"ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 18X220mm","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":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K141990","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"13180","gmdnPTName":"Orthopaedic prosthesis implantation positioning instrument, reusable","gmdnPTDefinition":"A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HSD","productCodeName":"Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented"},{"productCode":"KWS","productCodeName":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented"},{"productCode":"PHX","productCodeName":"Shoulder Prosthesis, Reverse Configuration"}]},"deviceSizes":{"deviceSize":[]},"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}