510(k) Report

Devices descending from K121443

37 later devices reach Journey II CR Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+1K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+1K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211—
+1K200407LEGION Inserts with JRNY LockSmith & Nephew, Inc.20202—
+1K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+1K141471Journey II XR Knee SystemSmith & Nephew, Inc.201412—
+1K123692Pipeline Knee SystemPipeline Orthopedics20130—
+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—
+2K220896Legion Inserts with JRNY LockSmith & Nephew, Inc.20221—
+2K201084Physica systemLima Corporate S.P.A.20205—
+2K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+2K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+2K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+2K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+2K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158—
+2K152726JOURNEY II XR Knee SystemSmith & Nephew, Inc.20154—
+2K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+3K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+3K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+3K213381Physica systemLima Corporate S.P.A.202101
+3K211938Physica LMC Knee SystemLimacorporate20210—
+3K210554Physica systemLima Corporate S.P.A.20212—
+3K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+3K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+4K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+4K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+4K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+4K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+4K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+5K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+6K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—