510(k) Report

Devices descending from K994370

47 later devices reach Ortho Development Balanced Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+1K131337Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaOrtho Development Corp.20133—
+1K123457Balanced Knee System High Flex PSOrtho Development Corp.20134—
+1K112906Klassic Knee SystemTotal Joint Orthopedics, Inc.201233—
+1K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp.2009421
+1K020383Ortho Development Balanced Knee Tibial Tray PeggedOrtho Development Corp.20020—
+2K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+2K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc.20251—
+2K233093Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation20230—
+2K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostTotal Joint Othopedics, Inc.20230—
+2K230537Klassic Knee Revision SystemTotal Joint Othopedics, Inc.20232—
+2K211602Klassic Knee SystemTotal Joint Orthopedics, Inc.20210—
+2K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post…Total Joint Orthopedics, Inc.20192—
+2K180159Klassic® Knee SystemTotal Joint Orthopedics, Inc.201822—
+2K162422Klassic Knee SystemTotal Joint Orthopedics, Inc.201623—
+2K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+2K153310Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+2K153075Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+2K150105Klassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc.201524—
+2K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc.201427—
+2K132752Ultracongruent InsertUnited Orthopedic Corporation20145—
+3K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+3K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+3K211877Klassic Knee SystemTotal Joint Orthopedics, Inc.20221—
+3K202740Klassic Knee System Tibial Inserts, PS-MaxTotal Joint Orthopedics, Inc.20200—
+3K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+3K190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System -…Total Joint Orthopedics, Inc.20190—
+3K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+3K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+3K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+4K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.202301
+4K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+4K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+4K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+4K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+4K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+5K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+5K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+5K203421Triathlon AS-1Conformis, Inc.20210—
+6K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+6K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+6K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+7K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+7K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+7K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+8K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+8K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301