510(k) Report

Devices descending from K082924

25 later devices reach Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201157Prime BIOFOAM® Multi-Hole ShellsMicroport Orthopedics, Inc.20210—
+1K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.20210—
+1K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+1K171181PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc.201710—
+1K170444PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc.201716—
+1K122382Dynasty Biofoam ShellWrightmedicaltechnologyinc20125—
+1K121544Dynasty Biofoam ShellWrightmedicaltechnologyinc20120—
+1K111910Gladiator Hip StemWrightmedicaltechnologyinc20115—
+1K110029Conserve Bio Foam ShellWrightmedicaltechnologyinc20110—
+2K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+2K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+2K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+2K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.20201—
+2K190123MicroPort CoCr Femoral HeadsMicroport Orthopedics, Inc.20191—
+2K181598Prime E-CLASS XLPE LinerMicroport Orthopedics, Inc.20181—
+2K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+2K180798Prime Acetabular Cup SystemMicroport Orthopedics, Inc.20182—
+2K170288BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION®…Microport Orthopedics, Inc.20172—
+3K252451EPORE® XO cup systemImplantcast GmbH20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+3K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+3K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+3K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—