510(k) Report

Devices descending from K141972

14 later devices reach Klassic HD Acetabular Insert with E-Link Poly through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+1K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+1K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+1K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+1K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+2K252451EPORE® XO cup systemImplantcast GmbH20260—
+2K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+2K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+2K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+2K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+2K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+2K203420EcoFit® Hip SystemImplantcast GmbH20214—
+2K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+3K243809Biolox® Delta Revision headsLimacorporate20250—