510(k) Report

Devices descending from K872379

55 later devices reach Insall/Burstein* II Modular Total Knee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.201852
+1K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp.2009421
+1K061433Vanguard Anatomic Patella Groove (Apg) / Vanguard V GrooveBiomet Manufacturing, Inc.20060—
+1K013906HLS Noetos SystemTornier20023—
+1K964951Kinemax Plus Tibial SpacersHowmedica Corp.19970—
+2K191625Persona Revision Knee SystemZimmer, Inc.201911
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+2K132752Ultracongruent InsertUnited Orthopedic Corporation20145—
+2K112906Klassic Knee SystemTotal Joint Orthopedics, Inc.201233—
+2K094013HLS Kneetec SystemTornier20111—
+2K032079HLS Noetos SystemTornier20030—
+3K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+3K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc.20251—
+3K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+3K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostTotal Joint Othopedics, Inc.20230—
+3K230537Klassic Knee Revision SystemTotal Joint Othopedics, Inc.20232—
+3K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+3K211602Klassic Knee SystemTotal Joint Orthopedics, Inc.20210—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K210551Persona Revision Knee SystemZimmer, Inc.202101
+3K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post…Total Joint Orthopedics, Inc.20192—
+3K180159Klassic® Knee SystemTotal Joint Orthopedics, Inc.201822—
+3K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+3K162422Klassic Knee SystemTotal Joint Orthopedics, Inc.201623—
+3K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+3K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+3K153310Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+3K153075Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+3K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+3K150105Klassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc.201524—
+3K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc.201427—
+3K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier20120—
+4K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+4K211877Klassic Knee SystemTotal Joint Orthopedics, Inc.20221—
+4K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+4K202740Klassic Knee System Tibial Inserts, PS-MaxTotal Joint Orthopedics, Inc.20200—
+4K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+4K190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System -…Total Joint Orthopedics, Inc.20190—
+5K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.202301
+5K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+5K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+5K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+5K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+6K203421Triathlon AS-1Conformis, Inc.20210—
+7K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+7K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+7K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+8K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+8K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+8K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+9K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+9K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301