510(k) Report

Devices descending from K040281

54 later devices reach LPS Metaphyseal Sleeve (Limb Preservation System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202248Attune Revision Sleeve LPS Femoral AdaptorsDepuy Ireland UC20201—
+1K071417Depuy LPS Diaphyseal and Metaphyseal SleevesDePuy Orthopaedics, Inc.20072Class I
+1K063633Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal SleevesDePuy Orthopaedics, Inc.2007311
+1K060515Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc.200636—
+2K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+2K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240—
+2K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+2K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191—
+2K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc.201427—
+2K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+2K110404Eaum Total Knee SystemCorentec Co., Ltd.2012142
+3K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+3K231975PNK Total Knee SystemTjc Life Co., Ltd.20230—
+3K230537Klassic Knee Revision SystemTotal Joint Othopedics, Inc.20232—
+3K222278LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationCorentec Co., Ltd.20220—
+3K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+3K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+3K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+3K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd.20210—
+3K203421Triathlon AS-1Conformis, Inc.20210—
+3K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+3K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+3K192507LOSPA II Knee SystemCorentec Co., Ltd.20197—
+3K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+3K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post…Total Joint Orthopedics, Inc.20192—
+3K170753Acculoc Total Knee SystemRootloc Co., Ltd.20183—
+3K180159Klassic® Knee SystemTotal Joint Orthopedics, Inc.201822—
+3K162422Klassic Knee SystemTotal Joint Orthopedics, Inc.201623—
+3K130673Lospa Total Knee Replacement SystemCorentec Co., Ltd.201392
+3K121037Lospa Tibial Base PlateCorentec Co., Ltd.201210—
+4K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc.20251—
+4K242401EXULT Knee Replacement SystemCorentec Co., Ltd.20240—
+4K242046EXULT Knee Replacement SystemCorentec Co., Ltd.20242—
+4K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostTotal Joint Othopedics, Inc.20230—
+4K211877Klassic Knee SystemTotal Joint Orthopedics, Inc.20221—
+4K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+4K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+4K202740Klassic Knee System Tibial Inserts, PS-MaxTotal Joint Orthopedics, Inc.20200—
+4K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.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—
+4K182370Acculoc Total Knee SystemRootloc Co., Ltd.20180—
+4K181146ASK SystemL and K Biomed Corporation Limited20180—
+5K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+5K250889EXULT Knee Replacement SystemCorentec Co., Ltd.20250—
+5K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+5K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.202301
+5K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+5K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+6K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+6K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+6K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+7K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+7K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301