<?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>67f92854-abb8-4a88-9239-bfd75c35b1a9</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2025-06-27</publicVersionDate><devicePublishDate>2025-06-19</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00840194479080</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>3P Hip System</brandName><versionModelNumber>00-3003-2405</versionModelNumber><catalogNumber>00-3003-2405</catalogNumber><dunsNumber>796416191</dunsNumber><companyName>ORTHOPEDIATRICS CORP.</companyName><deviceCount>1</deviceCount><deviceDescription>140° Child Flare Plate, 5-Hole</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>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Conditional</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(574)268-6379</phone><phoneExtension xsi:nil="true"/><email>xxx@xxx.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K243963</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>66945</gmdnCode><gmdnPTName>Femoral neck fixation plate/sleeve</gmdnPTName><gmdnPTDefinition>An implantable, non-bioabsorbable, non-customized sheet of firm material that incorporates a sleeve (commonly known as a barrel) at its proximal end designed to be attached with screws to the proximal femur to treat a femoral neck (trochanteric) fracture. The sleeve is intended to be introduced into the bone to hold a sliding screw (commonly known as a lag or dynamic screw) and/or a deployable-hook pin [not included] that is implanted into the femoral head/neck to compress the fracture. It is available in various sleeve angles/sizes. Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., cortical bone screws), may be included with the plate/sleeve.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>HRS</productCode><productCodeName>Plate, fixation, bone</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>