510(k) Report

Devices descending from K033363

144 later devices reach Zimmer Unicompartmental Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…Howmedica Osteonics Corp.20200—
+5K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+5K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+5K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+5K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+5K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+5K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+5K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp.201525—
+5K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+5K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+5K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+5K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+5K123692Pipeline Knee SystemPipeline Orthopedics20130—
+6K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+6K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+6K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+6K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+6K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+6K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+6K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+6K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+6K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+6K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+6K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+7K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+7K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+7K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+7K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+7K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+7K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+7K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+7K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+7K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+7K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+7K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+7K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+8K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+8K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+8K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+8K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+9K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+9K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301