510(k) Report

Devices descending from K051229

14 later devices reach Profix Flex Cruciate Retaining Articular Insert through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+1K113482Journey II Deep Dished Articular InsertsSmith & Nephew, Inc.20126—
+1K102927Consensus Knee SystemConsensus Orthopedics, Inc.20110—
+2K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+2K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211—
+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—
+3K250677LEGION Total Knee SystemSmith & Nephew, Inc.20250—
+3K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+3K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+3K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+3K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—