510(k) Report

Devices descending from K042992

168 later devices reach Corail Amt Hip Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+3K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+3K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+3K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+3K231925MINIMA S SystemLima Corporate S.P.A.20230—
+3K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+3K231178ACTERA™ hip systemConformis, Inc.20230—
+3K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+3K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+3K221104Actera™ hip systemConformis, Inc.202211
+3K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+3K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+3K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+3K211703Insignia Hip StemStryker Orthopaedics20217—
+3K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+3K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+3K203420EcoFit® Hip SystemImplantcast GmbH20214—
+3K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+3K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+3K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+3K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+3K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+3K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+3K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+3K171156OMNI Anseris Hip StemOmnilife Science20170—
+3K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+3K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K121563Corin Trifit TS HipCorin USA2012101
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+4K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+4K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+4K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+4K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+4K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+4K192126AMIStem-P Short NeckMedacta International S.A.20191—
+4K181254Quadra PMedacta International S.A.20187—
+4K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+4K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+4K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+5K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+5K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+5K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+5K202730Quadra-PMedacta International S.A.20201—
+5K192827Quadra-PMedacta International S.A.20206—
+5K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+6K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+6K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+6K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+6K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+6K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+6K220405Amis K LongMedacta International S.A.20220—
+6K210062Mectaplug PE IIMedacta International S.A.20210—
+6K203041SMS Cementless StemMedacta International S.A.20201—