510(k) Report

Devices descending from K071071

66 later devices reach Crosslinked Polyethylene Articular Inserts through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+1K220896Legion Inserts with JRNY LockSmith & Nephew, Inc.20221—
+1K200407LEGION Inserts with JRNY LockSmith & Nephew, Inc.20202—
+1K111711Journey II BCS Knee SystemSmith & Nephew, Inc.2011403
+1K093746Verilast Wear Claims for the Legion Primary Knee SystemSmith & Nephew, Inc.201029—
+2K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+2K250677LEGION Total Knee SystemSmith & Nephew, Inc.20250—
+2K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+2K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+2K230555Cemented Tibia Baseplate no Taper with JRNY LockSmith & Nephew, Inc.20230—
+2K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211—
+2K142787Zimmer Persona Personalized Knee SystemZimmer, Inc.201416—
+2K123692Pipeline Knee SystemPipeline Orthopedics20130—
+2K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+2K121443Journey II CR Knee SystemSmith & Nephew, Inc.201237—
+2K113482Journey II Deep Dished Articular InsertsSmith & Nephew, Inc.20126—
+2K112941Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral ComponentsSmith & Nephew, Inc.201183
+3K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+3K170648ANTHEM CR Total Knee SystemSmith & Nephew, Inc.20174—
+3K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+3K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—
+3K142807ANTHEM PS Total Knee SystemSmith & Nephew, Inc.20147—
+3K141471Journey II XR Knee SystemSmith & Nephew, Inc.201412—
+3K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+4K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+4K201084Physica systemLima Corporate S.P.A.20205—
+4K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+4K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+4K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+4K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+4K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+4K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158—
+4K150241Genesis II XLPE Resurfacing Patellar ComponentsSmith & Nephew, Inc.20150—
+4K152726JOURNEY II XR Knee SystemSmith & Nephew, Inc.20154—
+4K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+5K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+5K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+5K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+5K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K230078TRAX® CR Total Knee SystemAmplitude20230—
+5K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+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—
+5K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+5K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+6K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+6K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+6K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+6K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+6K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+6K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+7K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+7K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+7K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+8K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—