<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>e7ce6edd-de25-48c3-9310-97a5b974395d</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2022-12-22</publicVersionDate><devicePublishDate>2018-05-03</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>07613327123746</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>EXETER</brandName><versionModelNumber>0580-1-562</versionModelNumber><catalogNumber>0580-1-562</catalogNumber><dunsNumber>058311945</dunsNumber><companyName>Howmedica Osteonics Corp.</companyName><deviceCount>1</deviceCount><deviceDescription>EXETER STEM V40</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Conditional</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts/><gmdnTerms><gmdn><gmdnCode>34190</gmdnCode><gmdnPTName>Uncoated hip femur prosthesis, modular</gmdnPTName><gmdnPTDefinition>A sterile implantable principal component of a total hip prosthesis (femoral component) typically designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>LZO</productCode><productCodeName>Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented</productCodeName></fdaProductCode><fdaProductCode><productCode>JDG</productCode><productCodeName>Prosthesis, hip, femoral component, cemented, metal</productCodeName></fdaProductCode><fdaProductCode><productCode>KWY</productCode><productCodeName>Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented</productCodeName></fdaProductCode><fdaProductCode><productCode>JDI</productCode><productCodeName>Prosthesis, hip, semi-constrained, metal/polymer, cemented</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Size: 2</sizeText></deviceSize><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Offset: 56.0 Millimeter</sizeText></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>