510(k) Report

Devices descending from K000310

190 later devices reach Voyager 6.0 Software Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K231172ApolloKneeCorin U.S.A. Limited20230—
+7K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+7K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+7K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+7K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+7K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+7K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+7K173358ARTAS SystemRestoration Robotics, Inc.20180—
+7K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+7K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+7K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+7K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+7K160537NavioBlue Belt Technologies, Inc.201618—
+7K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+8K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+8K241470CORE Shoulder SystemLinkBio Corp.202501
+8K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+8K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+8K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+8K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+8K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+8K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+8K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+8K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+8K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+8K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+8K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+8K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+8K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+8K170360NAVIOBlue Belt Technologies, Inc.201717—
+8K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+9K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+9K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+9K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+9K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+9K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+9K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+9K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+9K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+9K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+9K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+9K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+9K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+9K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+9K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+9K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+9K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+9K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+9K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+9K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+9K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+9K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+9K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+10K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+10K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+10K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+10K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+10K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+10K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+10K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+10K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+10K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+10K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+10K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+10K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+10K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+10K191223NAVIOBlue Belt Technologies, Inc.201915—
+11K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+11K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+11K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+11K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+11K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+11K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+11K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+11K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+12K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+12K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+12K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+12K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+13K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+13K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+13K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—
+14K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+14K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+15K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+16K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+17K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+18K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+19K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601