510(k) Report

Devices descending from K111910

5 later devices reach Gladiator Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+1K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.20201—
+1K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+2K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+2K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—