510(k) Report

Devices descending from K060192

111 later devices reach Apex Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201611Apex Knee SystemOmnilife Science20210—
+1K112891Apex Revision Knee SystemsOmni Life Science, Inc.201251
+1K112906Klassic Knee SystemTotal Joint Orthopedics, Inc.201233—
+1K111062Apex Knee System, Apex All Poly TibiaOmni Life Science, Inc.20110—
+1K102578Apex PS Knee SystemOmni Life Science, Inc.20118—
+1K101994Apex Knee Modular Tibia SystemOmnlife Science201061
+1K094017Tibial Baseplate Augment Model KC-22118, KC-22128, KC-22138, KC-22148, KC-22158Omni Life Science, Inc.201076
+1K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc.200861—
+1K073602Modification to: Apex Knee SystemOmnlife Science200872—
+2K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.20260—
+2K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc.20251—
+2K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostTotal Joint Othopedics, Inc.20230—
+2K230537Klassic Knee Revision SystemTotal Joint Othopedics, Inc.20232—
+2K211602Klassic Knee SystemTotal Joint Orthopedics, Inc.20210—
+2K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post…Total Joint Orthopedics, Inc.20192—
+2K180159Klassic® Knee SystemTotal Joint Orthopedics, Inc.201822—
+2K162422Klassic Knee SystemTotal Joint Orthopedics, Inc.201623—
+2K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+2K153437Apex Revision Knee SystemOmnilife Science201541
+2K153310Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+2K153075Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+2K150105Klassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc.201524—
+2K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc.201427—
+2K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+2K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.20135—
+2K111184Apex PS Knee System - PS-C InsertOmni Life Science, Inc.20112—
+3K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+3K240875Unity Knee PS-C Tibial InsertCorin U.S.A. Limited20240—
+3K211877Klassic Knee SystemTotal Joint Orthopedics, Inc.20221—
+3K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+3K202740Klassic Knee System Tibial Inserts, PS-MaxTotal Joint Orthopedics, Inc.20200—
+3K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+3K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+3K190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System -…Total Joint Orthopedics, Inc.20190—
+3K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+3K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+3K163332Apex Revision Knee SystemOmnilife Science20173—
+3K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+4K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+4K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+4K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+4K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+4K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+4K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+4K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.202301
+4K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+4K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+4K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+4K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+4K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+4K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+4K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+4K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+4K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+4K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+4K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+4K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+5K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+5K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+5K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+5K250644MSS - Monobloc stemMedacta International S.A.202611
+5K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+5K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+5K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K241043Augment Off-Axis Instrument SystemFix Surgical202415
+5K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+5K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+5K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+5K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+5K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+5K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+5K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+5K203421Triathlon AS-1Conformis, Inc.20210—
+5K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+6K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+6K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+6K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+6K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+6K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+6K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+6K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+6K201315PERFORM Humeral System – StemTornier, Inc.2020111
+7K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+7K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+7K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+7K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+7K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+7K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+7K223876SMR Shoulder SystemLima Corporate S.P.A.20233—