510(k) Report

Devices descending from K023357

480 later devices reach Arcpm 1050 Resin-Hips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+8K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+8K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+8K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+9K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+9K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+9K250644MSS - Monobloc stemMedacta International S.A.202611
+9K254003JARVIS Metaphyseal StemFH Industrie20260—
+9K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+9K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+9K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P.20250—
+9K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.20250—
+9K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+9K243248Inhance Intact™Depuy Ireland UC20240—
+9K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+9K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+9K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+9K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+9K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+9K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+9K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+9K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+9K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+9K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+9K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+9K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+9K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+9K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+9K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+9K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+9K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+9K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+9K171249Entrada™ hip stemOrtho Development Corporation20172—
+9K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+9K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+9K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+9K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+9K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+9K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+9K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+9K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+10K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+10K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+10K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+10K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+10K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+10K251166Mfinity Femoral SystemMedacta International S.A.20250—
+10K251052Trivicta® Hip StemOrtho Development Corp.20250—
+10K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+10K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+10K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+10K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+10K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+10K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+10K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+10K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+10K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+10K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+10K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+10K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+10K211703Insignia Hip StemStryker Orthopaedics20217—
+10K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+10K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+10K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+10K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+10K171156OMNI Anseris Hip StemOmnilife Science20170—
+10K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+10K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+11K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+11K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+11K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+11K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+11K221104Actera™ hip systemConformis, Inc.202211
+11K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+12K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+12K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+12K231178ACTERA™ hip systemConformis, Inc.20230—
+13K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+13K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+13K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—