<?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>bf4729c3-0137-4d74-b347-0434f6324096</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2024-04-09</publicVersionDate><devicePublishDate>2024-04-01</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00822409123773</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>Trivicta</brandName><versionModelNumber>513-1012</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>876542390</dunsNumber><companyName>Ortho Development Corporation</companyName><deviceCount>1</deviceCount><deviceDescription>Collarless EXT Size 12</deviceDescription><DMExempt>true</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(801)553-9991</phone><phoneExtension xsi:nil="true"/><email>customerservice@odev.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>55834</gmdnCode><gmdnPTName>Press-fit hip femur prosthesis, one-piece</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 one-piece and is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device may be made of metal and/or ceramic materials; supplemental fixation devices for implantation (e.g., screws and bolts) may be included.</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>MEH</productCode><productCodeName>Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate</productCodeName></fdaProductCode><fdaProductCode><productCode>KWL</productCode><productCodeName>Prosthesis, hip, hemi-, femoral, metal</productCodeName></fdaProductCode><fdaProductCode><productCode>LZO</productCode><productCodeName>Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>