510(k) Report

Devices descending from K972401

78 later devices reach Howmedica Modular Replacement System - Distal Femoral/Proximal Tibial Segments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043547Compress Segmental Femoral Replacement SystemBiomet, Inc.2005116
+1K041352Compress Distal Femoral Replacement SystemBiomet, Inc.200412—
+1K031804Compress Distal Femoral ReplacementBiomet, Inc.200313—
+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—
+2K101475Compress Anti-Rotation SpindlesBiomet Manufacturing Corp20101—
+2K081860Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary SegmentsZimmer, Inc.200811
+2K080330Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female…Biomet, Inc.20082—
+2K063686Depuy LPS Distal Femoral ComponentDePuy Orthopaedics, Inc.20070—
+2K071417Depuy LPS Diaphyseal and Metaphyseal SleevesDePuy Orthopaedics, Inc.20072Class I
+2K062998Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)Biomet Manufacturing Corp20071021
+2K041085LPS (Limb Preservation System) Lower Extremity Dovetail IntercalaryDepuy, Inc.20040Class I
+2K040281LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc.200454—
+2K033959LPSDepuy, Inc.20043—
+3K202248Attune Revision Sleeve LPS Femoral AdaptorsDepuy Ireland UC20201—
+3K192798Zimmer Segmental SystemZimmer, Inc.20200—
+3K183553Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc.20190—
+3K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+3K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC201252
+3K063633Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal SleevesDePuy Orthopaedics, Inc.2007311
+3K062301Depuy LPS Proximal Tibial ComponentDePuy Orthopaedics, Inc.20060—
+3K060515Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc.200636—
+4K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+4K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+4K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240—
+4K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+4K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191—
+4K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182—
+4K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc.201427—
+4K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+4K123297Compress Segmental Humeral Replacement SystemBiomet Manufactuting Corp.20121—
+4K110404Eaum Total Knee SystemCorentec Co., Ltd.2012142
+5K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+5K231975PNK Total Knee SystemTjc Life Co., Ltd.20230—
+5K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+5K230537Klassic Knee Revision SystemTotal Joint Othopedics, Inc.20232—
+5K222278LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationCorentec Co., Ltd.20220—
+5K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+5K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+5K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+5K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd.20210—
+5K203421Triathlon AS-1Conformis, Inc.20210—
+5K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+5K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+5K192507LOSPA II Knee SystemCorentec Co., Ltd.20197—
+5K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+5K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post…Total Joint Orthopedics, Inc.20192—
+5K170753Acculoc Total Knee SystemRootloc Co., Ltd.20183—
+5K180159Klassic® Knee SystemTotal Joint Orthopedics, Inc.201822—
+5K162422Klassic Knee SystemTotal Joint Orthopedics, Inc.201623—
+5K130673Lospa Total Knee Replacement SystemCorentec Co., Ltd.201392
+5K121037Lospa Tibial Base PlateCorentec Co., Ltd.201210—
+6K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+6K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc.20251—
+6K242401EXULT Knee Replacement SystemCorentec Co., Ltd.20240—
+6K242046EXULT Knee Replacement SystemCorentec Co., Ltd.20242—
+6K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostTotal Joint Othopedics, Inc.20230—
+6K211877Klassic Knee SystemTotal Joint Orthopedics, Inc.20221—
+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
+6K202740Klassic Knee System Tibial Inserts, PS-MaxTotal Joint Orthopedics, Inc.20200—
+6K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+6K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+6K190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System -…Total Joint Orthopedics, Inc.20190—
+6K182370Acculoc Total Knee SystemRootloc Co., Ltd.20180—
+6K181146ASK SystemL and K Biomed Corporation Limited20180—
+7K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+7K250889EXULT Knee Replacement SystemCorentec Co., Ltd.20250—
+7K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+7K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.202301
+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