510(k) Report

Devices descending from K100445

25 later devices reach Klassic HD Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+1K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+1K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+1K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+1K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+1K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+1K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+1K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+1K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+1K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+1K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+1K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+2K243809Biolox® Delta Revision headsLimacorporate20250—
+2K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+2K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+2K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+2K163577Ecofit® Hip SystemImplantcast GmbH201791
+3K252451EPORE® XO cup systemImplantcast GmbH20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+3K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+3K210678implaFit® hip stemsImplantcast GmbH20223—
+3K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K252401implaFit® short stemsImplantcast GmbH20260—
+4K232371Actinia® hip stemsImplantcast GmbH20231—