510(k) Report

Devices descending from K951262

232 later devices reach Operating Arm System (Oas) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+8K182359HipCheckStryker Corp.20181—
+8K173946ADAPT for Gamma3Stryker GmbH20182—
+8K172054Materialise Glenoid Positioning SystemMaterialise NV20170—
+8K170893Materialise Glenoid Positioning SystemMaterialise NV201711
+8K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+8K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+8K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+8K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+8K152574NavioBlue Belt Technologies, Inc.201519—
+8K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+8K120812RenaissanceMazor Robotics, Ltd.2012211
+8K113228Renaissance SystemMazor Robotics, Ltd.201123—
+9K243509Archer PSI System3D-Side20250—
+9K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+9K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+9K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+9K230045HipCheckStryker Corp.20230—
+9K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+9K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+9K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+9K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+9K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+9K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+9K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+9K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+9K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+9K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+9K160537NavioBlue Belt Technologies, Inc.201618—
+9K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+9K140167Renaissance X SystemMazor Robotics, Ltd.201421—
+10K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+10K241470CORE Shoulder SystemLinkBio Corp.202501
+10K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+10K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+10K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+10K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+10K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+10K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+10K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+10K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+10K202749ADAPT for Gamma3Stryker GmbH20200—
+10K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+10K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+10K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+10K170360NAVIOBlue Belt Technologies, Inc.201717—
+10K163221Mazor XMazor Robotics, Ltd.201719—
+11K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+11K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+11K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+11K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+11K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+11K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+11K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+11K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+11K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+11K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+11K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+11K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+11K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+11K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+11K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+11K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+11K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+11K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+11K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+11K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+11K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+11K180307Mazor XMazor Robotics, Ltd.201817—
+11K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+11K172522Mazor XMazor Robotics, Ltd.20170—
+12K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+12K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+12K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+12K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+12K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+12K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+12K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+12K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+12K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+12K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+12K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+12K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+12K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+12K191223NAVIOBlue Belt Technologies, Inc.201915—
+12K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+13K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+13K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+13K252847NextAR Hip PlatformMedacta International S.A.20260—
+13K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+13K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+13K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+13K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+13K200935Mazor XMazor Robotics, Ltd.202015—
+13K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+14K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+14K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+14K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+14K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+14K203005Mazor XMazor Robotics, Ltd.2020141