510(k) Report

Devices descending from K060515

36 later devices reach Depuy PFC Sigma 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—
+1K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+1K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191—
+1K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+1K110404Eaum Total Knee SystemCorentec Co., Ltd.2012142
+2K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+2K231975PNK Total Knee SystemTjc Life Co., Ltd.20230—
+2K222278LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationCorentec Co., Ltd.20220—
+2K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+2K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+2K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+2K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd.20210—
+2K203421Triathlon AS-1Conformis, Inc.20210—
+2K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+2K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+2K192507LOSPA II Knee SystemCorentec Co., Ltd.20197—
+2K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+2K170753Acculoc Total Knee SystemRootloc Co., Ltd.20183—
+2K130673Lospa Total Knee Replacement SystemCorentec Co., Ltd.201392
+2K121037Lospa Tibial Base PlateCorentec Co., Ltd.201210—
+3K242401EXULT Knee Replacement SystemCorentec Co., Ltd.20240—
+3K242046EXULT Knee Replacement SystemCorentec Co., Ltd.20242—
+3K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+3K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+3K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+3K182370Acculoc Total Knee SystemRootloc Co., Ltd.20180—
+3K181146ASK SystemL and K Biomed Corporation Limited20180—
+4K250889EXULT Knee Replacement SystemCorentec Co., Ltd.20250—
+4K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+4K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+4K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+5K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+5K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+5K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+6K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+6K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301