<?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>e5c2a64d-3447-4ad6-a657-669b46cacf34</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2024-12-24</publicVersionDate><devicePublishDate>2024-12-16</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00846832094271</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>Tornier Perform Humeral System</brandName><versionModelNumber>ARS1022404</versionModelNumber><catalogNumber>ARS1022404</catalogNumber><dunsNumber>968990812</dunsNumber><companyName>TORNIER, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>VE 10° Reversed Insert, 55%</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>false</lotBatch><serialNumber>true</serialNumber><manufacturingDate>true</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(888)494-7950</phone><phoneExtension xsi:nil="true"/><email>customerservice@tornier.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K241878</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>48092</gmdnCode><gmdnPTName>Polyethylene reverse shoulder prosthesis cup</gmdnPTName><gmdnPTDefinition>A sterile component of a reverse shoulder prosthesis that consists of a polyethylene (PE) cup intended to be attached to a humeral stem prosthesis, or humeral body component, and to articulate with the reverse shoulder head.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>PHX</productCode><productCodeName>shoulder prosthesis, reverse configuration</productCodeName></fdaProductCode><fdaProductCode><productCode>HSD</productCode><productCodeName>PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED</productCodeName></fdaProductCode><fdaProductCode><productCode>KWS</productCode><productCodeName>PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Thickness -2 mm</sizeText></deviceSize><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Size: 3 / 4</sizeText></deviceSize><deviceSize><sizeType>Outer Diameter</sizeType><size unit="Millimeter" value="36"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>