510(k) Report

Devices descending from K052917

178 later devices reach Stryker Compartmental Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+5K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+5K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+5K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+5K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+5K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+5K213381Physica systemLima Corporate S.P.A.202101
+5K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+5K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+5K201611Apex Knee SystemOmnilife Science20210—
+5K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+5K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+5K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC20201—
+5K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+5K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+5K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+5K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+5K152252Arthrex iBalance TKA SystemArthrex, Inc.20152—
+5K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+5K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+5K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+5K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+5K130084Milestone Revision Knee System (MRKS) - Femoral Component, Tibial Baseplate, Tibial…Tgm Medical, Inc.20130—
+6K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+6K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+6K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+6K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+6K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+6K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+6K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC20240—
+6K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+6K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+6K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+6K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+6K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+6K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+6K153586Arthrex iBalance TKA SystemArthrex, Inc.20161—
+6K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+6K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+6K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+7K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+7K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+7K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+7K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+7K211938Physica LMC Knee SystemLimacorporate20210—
+7K201084Physica systemLima Corporate S.P.A.20205—
+7K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+7K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+7K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+7K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+8K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+8K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+8K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+8K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+8K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+8K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+8K210554Physica systemLima Corporate S.P.A.20212—
+8K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+8K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+8K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+8K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+8K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+9K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+9K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+9K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+9K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+9K203421Triathlon AS-1Conformis, Inc.20210—
+9K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+10K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+10K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+11K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+11K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+11K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+12K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+13K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301