510(k) Report

Devices descending from K833921

149 later devices reach Agc Total Knee Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K211768LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPEWaldemar Link GmbH & Co. KG20210—
+5K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG2021211
+5K201611Apex Knee SystemOmnilife Science20210—
+5K210308EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P.20210—
+5K210551Persona Revision Knee SystemZimmer, Inc.202101
+5K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+5K191755SPAR-K Instruments (for use with Gemini SL Total Knee System)Waldemar Link GmbH & Co. KG20190—
+5K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+5K153437Apex Revision Knee SystemOmnilife Science201541
+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—
+6K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P.20250—
+6K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.20250—
+6K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+6K211664GMK Sphere RevisionMedacta International S.A.20210—
+6K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+6K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+6K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+6K163332Apex Revision Knee SystemOmnilife Science20173—
+6K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+6K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+6K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+7K203421Triathlon AS-1Conformis, Inc.20210—
+7K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+7K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+7K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+7K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+8K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+8K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+8K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+8K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+8K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+8K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+8K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+8K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+9K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+9K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+9K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+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—
+10K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+11K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+11K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+11K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+12K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+12K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301