510(k) Report

Devices descending from K052915

8 later devices reach Profemur XTR Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+1K130167Profemur XM Distal CentralizerWrightmedicaltechnologyinc20132—
+1K113019Profemur XM Wingless Distal Centralizer, Perfecta Distal CentralizerWrightmedicaltechnologyinc20110—
+1K111910Gladiator Hip StemWrightmedicaltechnologyinc20115—
+2K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+2K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+2K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.20201—
+3K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—