510(k) Report

Devices descending from K171181

10 later devices reach PROCOTYL® PRIME E-CLASS™ XLPE Liner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+1K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+1K181598Prime E-CLASS XLPE LinerMicroport Orthopedics, Inc.20181—
+1K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+2K252451EPORE® XO cup systemImplantcast GmbH20260—
+2K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+2K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+2K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+2K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+2K203420EcoFit® Hip SystemImplantcast GmbH20214—