510(k) Report

Devices descending from K870730

64 later devices reach Noiles Total Knee Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240—
+1K040281LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc.200454—
+1K033959LPSDepuy, Inc.20043—
+1K003182Orthogenesis LPS SystemDepuy, Inc.200163—
+2K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…Depuy Ireland UC20240—
+2K211677ELEOS Limb Salvage SystemOnkos Surgical20210—
+2K202248Attune Revision Sleeve LPS Femoral AdaptorsDepuy Ireland UC20201—
+2K081860Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary SegmentsZimmer, Inc.200811
+2K063686Depuy LPS Distal Femoral ComponentDePuy Orthopaedics, Inc.20070—
+2K071417Depuy LPS Diaphyseal and Metaphyseal SleevesDePuy Orthopaedics, Inc.20072Class I
+2K063633Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal SleevesDePuy Orthopaedics, Inc.2007311
+2K062301Depuy LPS Proximal Tibial ComponentDePuy Orthopaedics, Inc.20060—
+2K060515Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc.200636—
+2K041085LPS (Limb Preservation System) Lower Extremity Dovetail IntercalaryDepuy, Inc.20040Class I
+3K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+3K192798Zimmer Segmental SystemZimmer, Inc.20200—
+3K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+3K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191—
+3K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc.201427—
+3K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+3K110404Eaum Total Knee SystemCorentec Co., Ltd.2012142
+4K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+4K231975PNK Total Knee SystemTjc Life Co., Ltd.20230—
+4K230537Klassic Knee Revision SystemTotal Joint Othopedics, Inc.20232—
+4K222278LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationCorentec Co., Ltd.20220—
+4K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+4K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+4K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+4K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd.20210—
+4K203421Triathlon AS-1Conformis, Inc.20210—
+4K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+4K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+4K192507LOSPA II Knee SystemCorentec Co., Ltd.20197—
+4K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+4K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post…Total Joint Orthopedics, Inc.20192—
+4K170753Acculoc Total Knee SystemRootloc Co., Ltd.20183—
+4K180159Klassic® Knee SystemTotal Joint Orthopedics, Inc.201822—
+4K162422Klassic Knee SystemTotal Joint Orthopedics, Inc.201623—
+4K130673Lospa Total Knee Replacement SystemCorentec Co., Ltd.201392
+4K121037Lospa Tibial Base PlateCorentec Co., Ltd.201210—
+5K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc.20251—
+5K242401EXULT Knee Replacement SystemCorentec Co., Ltd.20240—
+5K242046EXULT Knee Replacement SystemCorentec Co., Ltd.20242—
+5K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostTotal Joint Othopedics, Inc.20230—
+5K211877Klassic Knee SystemTotal Joint Orthopedics, Inc.20221—
+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
+5K202740Klassic Knee System Tibial Inserts, PS-MaxTotal Joint Orthopedics, Inc.20200—
+5K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+5K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+5K190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System -…Total Joint Orthopedics, Inc.20190—
+5K182370Acculoc Total Knee SystemRootloc Co., Ltd.20180—
+5K181146ASK SystemL and K Biomed Corporation Limited20180—
+6K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+6K250889EXULT Knee Replacement SystemCorentec Co., Ltd.20250—
+6K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+6K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.202301
+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