510(k) Report

Devices descending from K032683

19 later devices reach Genesis II Porous Plus HA Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190577World Knee Total Knee SystemsSignature Orthopaedics Pty, Ltd.20195—
+1K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+1K100897Legion Porous + HA Tibial BaseplatesSmith & Nephew, Inc.201012—
+2K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+2K220737World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal…Signature Orthopaedics Pty, Ltd.20224—
+2K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.20215—
+2K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+2K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+2K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+3K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+3K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+3K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+3K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+3K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+3K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—
+4K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+4K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—