510(k) Report

Devices descending from K100391

53 later devices reach Depuy Universal Gription TF Cones through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+1K212746ATTUNE Revision ConesDepuy Ireland UC20221—
+1K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+1K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics2015401
+1K123924Depuy Gription TF 5.5MM Sterile Locking ScrewsDepuy Orthopaedics20137—
+2K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc.20250—
+2K251718ArTT Augments and Buttresses and Bone ScrewsLima Corporate S.P.A.20250—
+2K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+2K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+2K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+2K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+2K230295ATTUNE® Revision ConesDepuy Ireland UC20230—
+2K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+2K200653AMF Revision TT ConesLima Corporate S.P.A.20203—
+2K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+2K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+2K153595Optetrak Logic Metaphyseal ConesExactech, Inc.20168—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+3K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+3K252067Velora Acetabular SystemRestor3D, 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—
+3K240324EMPOWR Revision Symmetric Knee ConesEncore Medical, L.P. (Dba Enovis)20241—
+3K234011AMF TT ConesLima Corporate S.P.A.20240—
+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
+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—
+3K200113LINK TrabecuLink Tibial ConesWaldemar Link GmbH & Co. KG20201—
+3K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+3K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.20185—
+3K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+3K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+4K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+4K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+4K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.20250—
+4K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc.20253—
+4K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+4K240393Exactech® TRULIANT® Knee SystemExactech, Inc.20240—
+4K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+4K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+4K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+4K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+4K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+4K201364LINK TrabecuLink Femoral ConesWaldemar Link GmbH & Co. KG20200—
+5K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+5K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+5K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+5K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.20251—