<?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>5140104d-ae67-43d8-bbfb-b0e5555f802e</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2021-07-14</publicVersionDate><devicePublishDate>2016-03-09</devicePublishDate><deviceCommDistributionEndDate>2021-07-14</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>09340499005447</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>GRU Femur</brandName><versionModelNumber>GRU-RL/LM-1F-C</versionModelNumber><catalogNumber>GRU-RL/LM-1F-C</catalogNumber><dunsNumber>752039982</dunsNumber><companyName>GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED</companyName><deviceCount>1</deviceCount><deviceDescription>GRU Femur RLLM Size 1</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>+6128870100</phone><phoneExtension xsi:nil="true"/><email>info@globalortho.com.au</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K051721</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>33369</gmdnCode><gmdnPTName>Uncoated unicondylar knee femur prosthesis</gmdnPTName><gmdnPTDefinition>A sterile implantable device designed to replace the bearing surface of one femoral condyle (femoral component) during primary or revision unicompartmental replacement of the knee joint. It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device articulates with a tibial component and an insert, and its implantation is intended to be performed with bone cement.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>HRY</productCode><productCodeName>Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Size 0</sizeText></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>