510(k) Report

Devices descending from K013569

153 later devices reach Orthopilot 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+8K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+8K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+8K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+8K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+8K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+8K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+8K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+8K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+8K172886Breakaway Screw SystemParagon 2820174—
+8K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+8K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+8K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+9K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+9K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+9K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+9K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+9K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+9K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+9K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+9K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+9K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+9K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+9K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+9K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+9K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+9K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+9K201149CoLink Plating SystemIn2bones USA, LLC20200—
+9K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+9K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+9K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+10K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+10K252246Leforte MMF SystemJeil Medical Corporation20260—
+10K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+10K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+10K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+10K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+10K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+10K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+10K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+10K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+10K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+10K192592Axis Plating SystemExtremity Medical, LLC20190—
+10K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+11K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+11K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+11K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+11K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+12K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+12K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+12K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+13K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+14K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—