510(k) Report

Devices descending from K951262

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+15K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+15K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+15K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+15K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+16K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+16K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+16K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+16K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+16K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+16K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+16K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+16K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+17K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+17K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+17K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+17K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+17K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+17K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+17K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+17K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+17K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+18K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+18K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+18K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+18K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+18K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+19K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+19K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+19K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+19K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+20K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+21K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601