510(k) Report

Devices descending from K884796

19 later devices reach P.F.C.(TM) Modular Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240—
+1K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191—
+1K102367Optigen Total Knee SystemU&I Corp.20100—
+1K984158P.F.C. Modular Plus Offset Tibial TrayDepuy, Inc.19997—
+1K954818Consensus Posterior Stabilized KneeU.S. Medical Products, Inc.19969—
+2K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd.20210—
+2K163167CKS Plus Knee SystemConsensus Orthopedics, Inc.20173—
+2K160515PS2 Knee SystemConsensus Orthopedics, Inc.20162—
+2K112285Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated…Tgm Medical, Inc.20111—
+2K094013HLS Kneetec SystemTornier20111—
+2K032079HLS Noetos SystemTornier20030—
+2K013906HLS Noetos SystemTornier20023—
+3K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC20201—
+3K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+3K130084Milestone Revision Knee System (MRKS) - Femoral Component, Tibial Baseplate, Tibial…Tgm Medical, Inc.20130—
+3K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier20120—
+4K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+4K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC20240—
+4K201611Apex Knee SystemOmnilife Science20210—