510(k) Report

Devices descending from K162719

17 later devices reach iTotal® Hip Replacement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202484Cordera Hip SystemConformis, Inc.202022
+1K192198Conformis Hip SystemConformis, Inc.2019121
+1K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+2K252067Velora Acetabular SystemRestor3D, Inc.20250—
+2K231178ACTERA™ hip systemConformis, Inc.20230—
+2K221104Actera™ hip systemConformis, Inc.202211
+2K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+2K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+2K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+3K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+3K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+4K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+4K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+4K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+4K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+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—