510(k) Report

Devices descending from K991226

28 later devices reach Foundation Porous Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121024Linear Porous Coated Hip Stem, Size 5; Revelation Hip Stem, Size 8; Foundation Porous…Encore Medical L.P.20120—
+1K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+1K032385Global Press-Fit StemGlobal Medical Co.20030—
+2K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+2K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+2K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+2K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+2K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+2K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+2K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+2K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+2K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+2K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+2K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+2K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+3K243809Biolox® Delta Revision headsLimacorporate20250—
+3K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K232371Actinia® hip stemsImplantcast GmbH20231—