510(k) Report

Devices descending from K001284

751 later devices reach Stealthstation System Goldeneye Micro-Magnetic Tracking System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+12K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+12K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+12K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+12K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+12K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+12K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+12K201149CoLink Plating SystemIn2bones USA, LLC20200—
+12K191223NAVIOBlue Belt Technologies, Inc.201915—
+12K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+12K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+12K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+13K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+13K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+13K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+13K252246Leforte MMF SystemJeil Medical Corporation20260—
+13K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+13K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+13K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+13K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+13K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+13K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+13K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+13K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+13K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+13K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+13K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+13K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+13K192592Axis Plating SystemExtremity Medical, LLC20190—
+13K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+14K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+14K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+14K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+14K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+14K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+14K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+14K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+15K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+15K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+15K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+15K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+15K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+16K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+16K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+16K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+17K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+17K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+18K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+19K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+20K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+21K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601