510(k) Report

Devices descending from K033810

20 later devices reach Natural-Knee II Unicompartmental Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133811Restoris Porous Partial Knee SystemMako Surgical Corp.201419—
+2K242307ACHIEVE Partial Knee SystemIgnite Orthomotion20241—
+2K190633NanoOrtho NanoKnee® SystemNanoortho, LLC20190—
+2K190439Engage™ Partial Knee SystemEngage Uni, LLC201954
+2K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+2K150410Restoris Porous Partial Knee SystemMako Surgical Corporation20150—
+3K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion20250—
+3K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+3K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+3K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+3K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+3K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+3K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20197—
+4K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+4K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+4K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+4K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+5K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—