510(k) Report

Devices descending from K953111

251 later devices reach Corail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+4K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+5K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+5K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+5K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+5K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+5K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+5K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+5K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+5K191831MobiliT CupCorin U.S.A. Limited20203—
+5K192126AMIStem-P Short NeckMedacta International S.A.20191—
+5K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+5K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+5K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+5K181254Quadra PMedacta International S.A.20187—
+5K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+5K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+5K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+5K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+5K123692Pipeline Knee SystemPipeline Orthopedics20130—
+5K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+5K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+5K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+5K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+6K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+6K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+6K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+6K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+6K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+6K202730Quadra-PMedacta International S.A.20201—
+6K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+6K192827Quadra-PMedacta International S.A.20206—
+6K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+6K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+7K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+7K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+7K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+7K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+7K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+7K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+7K220405Amis K LongMedacta International S.A.20220—
+7K210062Mectaplug PE IIMedacta International S.A.20210—
+7K203041SMS Cementless StemMedacta International S.A.20201—
+7K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—