510(k) Report

Devices descending from K031462

128 later devices reach The Nexgen Knee System Uncemented Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+4K200113LINK TrabecuLink Tibial ConesWaldemar Link GmbH & Co. KG20201—
+4K191625Persona Revision Knee SystemZimmer, Inc.201911
+4K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+4K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+4K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+4K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+4K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+4K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+4K153437Apex Revision Knee SystemOmnilife Science201541
+4K143635KINETIS Total Knee SystemMako Surgical20150—
+4K140257Signature Planner, Signature GuidesMaterialise NV20140—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+5K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.20251—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+5K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+5K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+5K210551Persona Revision Knee SystemZimmer, Inc.202101
+5K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+5K163332Apex Revision Knee SystemOmnilife Science20173—
+6K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+6K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+7K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+7K201611Apex Knee SystemOmnilife Science20210—