510(k) Report

Devices descending from K021346

19 later devices reach Stem Hip Replacement System, Model PHA002XX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+1K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+1K123434Profemur Z Classic StemsWrightmedicaltechnologyinc201321
+1K122778Profemur Z Revision Hip StemWrightmedicaltechnologyinc20120—
+1K121221Profemur Z Revision Hip StemWrightmedicaltechnologyinc20123—
+1K112080Preserve Hip StemWrightmedicaltechnologyinc20118—
+1K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc20114—
+1K111910Gladiator Hip StemWrightmedicaltechnologyinc20115—
+1K111699Profemur (R) Z Titanium Plasma Sprayed Hip StemWrightmedicaltechnologyinc20113—
+1K111698Profemur (R) E Cementless Hip StemWrightmedicaltechnologyinc201123
+1K110399Gladiator Plasma Classic Hip StemWrightmedicaltechnologyinc20112—
+2K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+2K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+2K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.20201—
+2K200007PROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarMicroport Orthopedics, Inc.20201—
+2K150133PROFEMUR Preserve Size 1-3 Hip StemsMicroport Orthopedics, Inc.20153—
+2K150302PROFEMUR Preserve Classic StemMicroport Orthopedics, Inc.20154—
+3K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+3K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—