510(k) Report

Devices descending from K955778

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033810Natural-Knee II Unicompartmental Knee SystemCenterpulse Orthopedics, Inc.2004201
+1K012800Symmetric Unicompartmental Knee SystemWhiteside Biomechanics, Inc.20020—
+2K133811Restoris Porous Partial Knee SystemMako Surgical Corp.201419—
+3K242307ACHIEVE Partial Knee SystemIgnite Orthomotion20241—
+3K190633NanoOrtho NanoKnee® SystemNanoortho, LLC20190—
+3K190439Engage™ Partial Knee SystemEngage Uni, LLC201954
+3K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+3K150410Restoris Porous Partial Knee SystemMako Surgical Corporation20150—
+4K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion20250—
+4K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+4K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+4K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+4K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+4K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+4K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20197—
+5K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+5K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+5K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+5K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+6K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—