<?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>83dd064e-38f2-4f14-b029-b2ca8a99e58f</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2024-11-13</publicVersionDate><devicePublishDate>2019-11-04</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00819251023191</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>Patella Calipers </brandName><versionModelNumber>2300.00.000</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>078416717</dunsNumber><companyName>TOTAL JOINT ORTHOPEDICS, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>Patella Calipers </deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</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(801)486-6070</phone><phoneExtension xsi:nil="true"/><email>udi@tjoinc.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>35788</gmdnCode><gmdnPTName>Orthopaedic bone calliper</gmdnPTName><gmdnPTDefinition>A hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>LXH</productCode><productCodeName>ORTHOPEDIC MANUAL SURGICAL INSTRUMENT</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>The Klassic Knee System should be stored in a clean, dry location at room 
temperature </storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>