<?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>4eb0ed5d-f3a9-4b13-9a83-3e4d6ce05190</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>7</publicVersionNumber><publicVersionDate>2026-01-29</publicVersionDate><devicePublishDate>2015-09-24</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>07613154058631</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>Restoration</brandName><versionModelNumber>6276-7-117</versionModelNumber><catalogNumber>6276-7-117</catalogNumber><dunsNumber>058311945</dunsNumber><companyName>Howmedica Osteonics Corp.</companyName><deviceCount>1</deviceCount><deviceDescription>Modular Hip System</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>38155</gmdnCode><gmdnPTName>Press-fit femoral stem prosthesis</gmdnPTName><gmdnPTDefinition>A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>LWJ</productCode><productCodeName>Prosthesis, hip, semi-constrained, metal/polymer, uncemented</productCodeName></fdaProductCode><fdaProductCode><productCode>KWZ</productCode><productCodeName>Prosthesis, hip, constrained, cemented or uncemented, metal/polymer</productCodeName></fdaProductCode><fdaProductCode><productCode>JDI</productCode><productCodeName>Prosthesis, hip, semi-constrained, metal/polymer, cemented</productCodeName></fdaProductCode><fdaProductCode><productCode>MAY</productCode><productCodeName>Prosthesis,  hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish</productCodeName></fdaProductCode><fdaProductCode><productCode>LPH</productCode><productCodeName>PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED</productCodeName></fdaProductCode><fdaProductCode><productCode>KWL</productCode><productCodeName>Prosthesis, hip, hemi-, femoral, metal</productCodeName></fdaProductCode><fdaProductCode><productCode>LZO</productCode><productCodeName>Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented</productCodeName></fdaProductCode><fdaProductCode><productCode>KWY</productCode><productCodeName>Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented</productCodeName></fdaProductCode><fdaProductCode><productCode>MBL</productCode><productCodeName>Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous</productCodeName></fdaProductCode><fdaProductCode><productCode>MEH</productCode><productCodeName>Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Distal Diameter: 17.0 Millimeter</sizeText></deviceSize><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Stem Length: 195.0 Millimeter</sizeText></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>