<?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>7b9ba31d-a873-4fc0-8caf-5e178d16d482</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>7</publicVersionNumber><publicVersionDate>2026-05-29</publicVersionDate><devicePublishDate>2015-09-28</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>03596010479396</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>ECHELON</brandName><versionModelNumber>71343017</versionModelNumber><catalogNumber>71343017</catalogNumber><dunsNumber>045483575</dunsNumber><companyName>Smith &amp; Nephew, Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>ECHELON 190MM POROUS PLUS HYDROXYAPATITE 15MM CALCAR SIZE 17</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>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(800)238-7538</phone><phoneExtension xsi:nil="true"/><email>GUDID@SMITH-NEPHEW.COM</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K090982</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission><premarketSubmission><submissionNumber>K211176</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission><premarketSubmission><submissionNumber>K963486</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>33581</gmdnCode><gmdnPTName>Coated hip femur prosthesis, modular</gmdnPTName><gmdnPTDefinition>A sterile implantable principal component of a total hip prosthesis (femoral component) 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 coated with a material (e.g., porous materials, hydroxyapatite) 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 may be performed with or without bone cement.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>LPH</productCode><productCodeName>PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED</productCodeName></fdaProductCode><fdaProductCode><productCode>JDI</productCode><productCodeName>Prosthesis, hip, semi-constrained, metal/polymer, cemented</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>