<?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>f911c021-6d29-4008-8e3b-a8dea21399c3</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2025-03-06</publicVersionDate><devicePublishDate>2020-07-21</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>03701037300916</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>TiN Coated Humeral Head</brandName><versionModelNumber>116-4818</versionModelNumber><catalogNumber>116-4818</catalogNumber><dunsNumber>263076196</dunsNumber><companyName>FX SOLUTIONS</companyName><deviceCount>1</deviceCount><deviceDescription>CENTERED HEAD CoCr/TiN 48x18 
</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/><premarketSubmissions><premarketSubmission><submissionNumber>K191698</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>48088</gmdnCode><gmdnPTName>Stem-fixed metallic humeral head prosthesis</gmdnPTName><gmdnPTDefinition>An implantable artificial substitute for a diseased or injured humeral head. It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and designed to be attached to a humeral stem prosthesis and to articulate with the natural glenoid fossa, a glenoid fossa prosthesis, or a humeral head bipolar component as part of a shoulder replacement.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>PHX</productCode><productCodeName>Shoulder Prosthesis, Reverse Configuration</productCodeName></fdaProductCode><fdaProductCode><productCode>KWT</productCode><productCodeName>Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Store away from light and sunlight Store away from moisture</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>