510(k) Report

Devices descending from K982302

107 later devices reach Implex Continuum Knee - Hedrocel Tibial Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103517Trabecular Metal Femoral Cone AugmentsZimmer Trabecular Metal Technology, Inc.201111—
+1K024161Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp.20031062
+2K201364LINK TrabecuLink Femoral ConesWaldemar Link GmbH & Co. KG20200—
+2K200653AMF Revision TT ConesLima Corporate S.P.A.20203—
+2K2000753DMetal Diaphyseal Femoral ConesMedacta International S.A.20200—
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K120990Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK…Zimmer Trabecular Metal Technology201271
+2K053505Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc.200619—
+2K040487Trabecular Metal Knee System AugmentsImplex Corp.2004851
+2K033260AequosAap Implantate AG200419—
+3K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+3K240324EMPOWR Revision Symmetric Knee ConesEncore Medical, L.P. (Dba Enovis)20241—
+3K234011AMF TT ConesLima Corporate S.P.A.20240—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K191625Persona Revision Knee SystemZimmer, Inc.201911
+3K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.20185—
+3K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+3K141840Trabecular Metal Tibial Cone Broach, Trabecular Metal Coupled Tibial Cone BroachZimmer, Inc.20140—
+3K100370Symmetric Total Knee AgumentsSignal Medical Corp.20110—
+3K080361Regenerex Tibial ComponentsBiomet, Inc.2008131
+3K072336Regenerex Porous Titanium Sleeve AugmentsBiomet Manufacturing Corp20074—
+3K053340Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular200674—
+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—
+4K240393Exactech® TRULIANT® Knee SystemExactech, Inc.20240—
+4K233507EVOLUTION® Tibial ConesMicroport Orthopedics, Inc.20240—
+4K210551Persona Revision Knee SystemZimmer, Inc.202101
+4K201084Physica systemLima Corporate S.P.A.20205—
+4K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K182085Balanced Knee Revision System Trabecular Tibial Cone AugmentsOrtho Development Corporation20180—
+4K1701493DMetal Tibial ConesMedacta International S.A.20170—
+4K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+4K162775Legion Cone SystemSmith & Nephew, Inc.201752
+4K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+4K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+4K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics2015401
+4K140883Vanguard 360 Osseoti Tibial Sleeve AugmentBiomet, Inc.20140—
+4K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc.201053—
+4K101994Apex Knee Modular Tibia SystemOmnlife Science201061
+5K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc.20250—
+5K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+5K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.20251—
+5K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+5K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+5K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+5K212746ATTUNE Revision ConesDepuy Ireland UC20221—
+5K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+5K213381Physica systemLima Corporate S.P.A.202101
+5K211938Physica LMC Knee SystemLimacorporate20210—
+5K210554Physica systemLima Corporate S.P.A.20212—
+5K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+5K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+5K180334LEGION Knee SystemSmith & Nephew, Inc.20184—
+5K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+5K153595Optetrak Logic Metaphyseal ConesExactech, Inc.20168—
+5K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.20135—
+5K123924Depuy Gription TF 5.5MM Sterile Locking ScrewsDepuy Orthopaedics20137—
+6K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+6K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+6K251718ArTT Augments and Buttresses and Bone ScrewsLima Corporate S.P.A.20250—
+6K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+6K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+6K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+6K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+6K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+6K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+6K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+6K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+6K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+6K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+6K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+6K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker20233—
+6K230295ATTUNE® Revision ConesDepuy Ireland UC20230—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+6K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+6K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+6K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+6K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…Howmedica Osteonics Corp.20200—
+6K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+6K200113LINK TrabecuLink Tibial ConesWaldemar Link GmbH & Co. KG20201—
+6K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+6K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+6K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+6K153437Apex Revision Knee SystemOmnilife Science201541
+7K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+7K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+7K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+7K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+7K252067Velora Acetabular SystemRestor3D, Inc.20250—
+7K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+7K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+7K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+7K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+7K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+7K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+7K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+7K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—