510(k) Report

Devices descending from K964008

21 later devices reach Foundation Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122239Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating…Encore Medical L.P.201320—
+2K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+2K241180Consensus Knee System with TiNbNShalby Advanced Technologies20251—
+2K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc.20202—
+2K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+2K182872LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG20198—
+2K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx…Waldemar Link GmbH & Co. KG2016916
+3K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+3K220628LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG20220—
+3K212839Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20211—
+3K212742GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK…Waldemar Link GmbH & Co. KG2021122
+3K211768LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPEWaldemar Link GmbH & Co. KG20210—
+3K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG2021211
+3K201611Apex Knee SystemOmnilife Science20210—
+3K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+3K191755SPAR-K Instruments (for use with Gemini SL Total Knee System)Waldemar Link GmbH & Co. KG20190—
+4K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+4K222816Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20220—
+4K211664GMK Sphere RevisionMedacta International S.A.20210—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+4K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—