510(k) Report

Devices descending from K974556

192 later devices reach Osteonics Scorpio Posterior Cruciate Retaining Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+1K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+1K123166Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…Howmedica Osteonics Corp.201333—
+1K113060Unity Toatal Knee SystemCorin USA201283
+1K091280Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc.20097—
+1K081127Accin Total Knee SystemAccelerated Innovation, LLC2008251
+1K032108Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc.200480—
+1K023788Columbus (CR) Total Knee SystemAesculap, Inc.200225—
+1K020703Scorpio CR and PS CO CR Femoral Components with Titanium Plasma Spray CoatingHowmedica Osteonics Corp.20020—
+1K022672Columbus Total Knee System (CR)Aesculap, Inc.2002961
+1K021313Search Evolution Total Knee SystemAesculap, Inc.2002120—
+1K011643Scorpio CR Superflex Tibial InsertHowmedica Osteonics Corp.200152
+2K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.20260—
+2K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+2K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+2K243817Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202522
+2K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+2K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+2K240875Unity Knee PS-C Tibial InsertCorin U.S.A. Limited20240—
+2K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc.20202—
+2K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+2K183533Unity Total Knee SystemCorin U.S.A. Limited20191—
+2K173884Unity Total Knee SystemCorin U.S.A. Limited20182—
+2K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+2K170808Unity Total Knee SystemCorin U.S.A. Limited20170—
+2K160771Destiknee Total Knee SystemMeril Healthcare Private Limited20163—
+2K153586Arthrex iBalance TKA SystemArthrex, Inc.20161—
+2K152252Arthrex iBalance TKA SystemArthrex, Inc.20152—
+2K152382Arthrex iBalance TKA SystemArthrex, Inc.20152—
+2K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+2K150680Freedom Cementless Femoral ComponentMaxx Orthopedics, Inc.20151—
+2K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+2K143047Arthrex iBalance Patella Implant, DomeArthrex, Inc.20142—
+2K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+2K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics20142811
+2K133854Arthrex Ibalance Tka SystemArthrex, Inc.20144—
+2K133342Arthrex Ibalance Tka SystemArthrex, Inc.20130—
+2K101032Cardo Medical Femoral Cement Restrictor, Model 503-MCRXCardo Medical, Inc.20100—
+2K092803Cardo Medical Align 360 Medialized Patella ComponentCardo Medical Corp.20090—
+2K083772Columbus Revision Knee SystemAesculap Implant System, Inc.2009124
+2K071499Columbus Total Knee System Mios CR/PS Tibial TrayAesculap Implant Systems, Inc.20076—
+2K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+2K071220Columbus Total Knee System asAesculap Implant Systems, Inc.200771
+2K053579Columbus Ultra Congruent (UC) Tibial Insert/Gliding SurfaceAesculap, Inc.20060—
+2K053390Columbus (CR) Total Knee SystemAesculap, Inc.200651
+2K033260AequosAap Implantate AG200419—
+2K030367Columbus (PS)Aesculap, Inc.2003171
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+3K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+3K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+3K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+3K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+3K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC20240—
+3K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+3K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+3K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker20233—
+3K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+3K213381Physica systemLima Corporate S.P.A.202101
+3K212839Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20211—
+3K211938Physica LMC Knee SystemLimacorporate20210—
+3K201084Physica systemLima Corporate S.P.A.20205—
+3K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+3K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+3K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…Howmedica Osteonics Corp.20200—
+3K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+3K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+3K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+3K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+3K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+3K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+3K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+3K172936Destiknee™ Total Knee SystemMeril Healthcare Pvt., Ltd.20172—
+3K171365Arthrex Knee SystemsArthrex, Inc.20170—
+3K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+3K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+3K143106VEGA Knee SystemAesculap Implant Systems, LLC20144—
+3K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC20124—
+3K122985Columbus Revision Knee SystemAesculap Implant System, Inc.201201
+3K101815Enduro Knee SystemAesculap Implant Systems201010—
+3K081023Evolis Total Knee SystemMedacta International S.A.2008781
+3K081293Univation Unicondylar Knee SystemAesculap Implant Systems, Inc.200818
+4K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+4K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+4K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+4K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+4K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+4K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+4K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+4K222816Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20220—
+4K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+4K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+4K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+4K210554Physica systemLima Corporate S.P.A.20212—
+4K201611Apex Knee SystemOmnilife Science20210—
+4K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+4K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+4K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+4K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—