Devices descending from K003347
436 later devices reach Orthopilot through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +9 | K260601 | Real Intelligence™ Cori™ | Blue Belt Technologies, Inc. | 2026 | 0 | — |
| +9 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with… | Alphatec Spine, Inc. | 2026 | 1 | — |
| +9 | K252788 | Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) | Tornier, Inc. | 2026 | 0 | — |
| +9 | K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG | 2025 | 1 | — |
| +9 | K250599 | ExcelsiusGPS™ Instruments | Globus Medical, Inc. | 2025 | 0 | — |
| +9 | K252376 | Yomi S Robotic System | Neocis, Inc. | 2025 | 0 | — |
| +9 | K251835 | Yomi Robotic System | Neocis, Inc. | 2025 | 0 | — |
| +9 | K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip… | Stryker Instruments | 2025 | 0 | — |
| +9 | K251060 | CORUS™ Navigation System-GX | Providence Medical Technology, Inc. | 2025 | 0 | — |
| +9 | K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2025 | 0 | — |
| +9 | K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac S | Brain Navi Biotechnology Co., Ltd. | 2025 | 0 | — |
| +9 | K241491 | Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid | Stryker Corporation (Tornier, S.A.S.) | 2024 | 1 | — |
| +9 | K233256 | Robotic Integration Instruments | DePuy Synthes | 2024 | 0 | — |
| +9 | K233228 | Spine Navigation and Robotic-Assistance Device | Ecential Robotics | 2024 | 2 | 1 |
| +9 | K233154 | SkyOPS™ Orthopedic Plate System | Sky Surgical, LLC | 2023 | 1 | — |
| +9 | K231887 | ARIX Ankle Distal Tibia System | Jeil Medical Corporation | 2023 | 1 | — |
| +9 | K231923 | Liberty SI Lateral Implant System | Spinal Simplicity, LLC | 2023 | 0 | — |
| +9 | K232533 | ROSA Partial Knee System | Orthosoft D/B/A Zimmer Cas | 2023 | 0 | — |
| +9 | K232802 | TMINI™ Miniature Robotic System | THINK Surgical, Inc. | 2023 | 9 | — |
| +9 | K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System… | Stryker GmbH | 2023 | 4 | — |
| +9 | K231257 | Pangea Utility Plating System, Pangea Platform | Stryker GmbH | 2023 | 1 | — |
| +9 | K231886 | SURGIVISIO Device | Ecential Robotics | 2023 | 6 | — |
| +9 | K230567 | OptiVu™ ROSA® MxR | Orthosoft Inc (D/B/A Zimmer Cas) | 2023 | 0 | — |
| +9 | K231162 | ROSA Hip System | Orthosoft Inc (D/B/A Zimmer Cas) | 2023 | 0 | — |
| +9 | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System | Stryker GmbH | 2023 | 8 | — |
| +9 | K230243 | ROSA® Knee System | Orthosoft D/B/A Zimmer Cas | 2023 | 6 | — |
| +9 | K230180 | Rosa Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2023 | 0 | — |
| +9 | K223070 | Remi Robotic Navigation System | Fusion Robotics, LLC | 2022 | 4 | — |
| +9 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS… | Globus Medical, Inc. | 2022 | 23 | — |
| +9 | K222698 | CUVIS-spine | Curexo, Inc. | 2022 | 0 | — |
| +9 | K212962 | TRELLIS™ SI Joint Fusion System | Orthofundamentals, LLC | 2022 | 0 | — |
| +9 | K212297 | Omni Foot and Ankle Plating System | Extremity Medical, LLC | 2021 | 1 | — |
| +9 | K203115 | ARVIS Surgical Navigation System | Insight Medical Systems, Inc. | 2021 | 3 | 2 |
| +9 | K200376 | Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration | Navbit Pty, Ltd. | 2020 | 1 | — |
| +9 | K201149 | CoLink Plating System | In2bones USA, LLC | 2020 | 0 | — |
| +9 | K200511 | ROSA ONE Brain application | Medtech S.A | 2020 | 5 | Class I |
| +9 | K193580 | VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona… | Orthosensor, Inc. | 2020 | 1 | — |
| +9 | K191369 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2019 | 5 | — |
| +9 | K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System | Paragon 28, Inc. | 2019 | 8 | — |
| +9 | K183011 | Additive Orthopaedics Patient Specific 3D Locking Lattice Plates | Additive Orthopaedics | 2019 | 5 | — |
| +9 | K180808 | Omni Foot Plating System | Extremity Medical, LLC | 2018 | 3 | — |
| +9 | K172301 | Mako Partial Knee Application | Mako Surgical Corp. | 2017 | 1 | 6 |
| +9 | K172219 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | 37 | — |
| +9 | K170360 | NAVIO | Blue Belt Technologies, Inc. | 2017 | 17 | — |
| +9 | K170593 | Mako Total Hip Application | Mako Surgical Corp. | 2017 | 7 | 1 |
| +10 | K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration… | Suite 201, National Innovation Centre | 2026 | 0 | — |
| +10 | K261113 | Op.n™ Spine Navigation and Robotic Guidance | Ecential Robotics | 2026 | 1 | — |
| +10 | K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System | Alphatec Spine, Inc. | 2026 | 0 | — |
| +10 | K261481 | Pangea Femur Reconstruction System | Stryker GmbH | 2026 | 0 | — |
| +10 | K253401 | SCRIPT™ Implant System | Globus Medical, Inc. | 2026 | 0 | — |
| +10 | K253674 | Blueprint Patient-Specific Instrumentation | Stryker Corporation (Tornier, S.A.S.) | 2026 | 0 | — |
| +10 | K252246 | Leforte MMF System | Jeil Medical Corporation | 2026 | 0 | — |
| +10 | K252037 | CUVIS-joint (CJ150) | Curexo, Inc. | 2026 | 0 | — |
| +10 | K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw… | CarboFix Orthopedics, Ltd. | 2026 | 0 | — |
| +10 | K251732 | Wrist Fracture System | Met One Technologies, LLC | 2026 | 0 | — |
| +10 | K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | 2026 | 1 | — |
| +10 | K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) | Globus Medical, Inc. | 2025 | 1 | — |
| +10 | K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion System | Degen Medical | 2025 | 0 | — |
| +10 | K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | 2025 | 2 | — |
| +10 | K243980 | ARVIS Surgical Navigation System | Kico Knee Innovation Company Pty Limited | 2025 | 0 | 1 |
| +10 | K242890 | SPINEART Navigation Instrument System | Spineart SA | 2025 | 3 | — |
| +10 | K241333 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | 2025 | 1 | — |
| +10 | K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2024 | 5 | — |
| +10 | K242373 | Mako Shoulder Application (1.0) | Mako Surgical Corp. | 2024 | 0 | — |
| +10 | K242864 | ROSA® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2024 | 1 | — |
| +10 | K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea… | Stryker GmbH | 2024 | 0 | — |
| +10 | K234035 | COSINE™ Spacer | Globus Medical, Inc. | 2024 | 0 | — |
| +10 | K241846 | E3D™-C Interbody System | Evolution Spine | 2024 | 6 | — |
| +10 | K234077 | SPIRA® Anterior Lumbar Spacers | Camber Spine Technologies | 2024 | 0 | — |
| +10 | K241031 | TMINI Miniature Robotic System (TMINI 1.1) | THINK Surgical, Inc. | 2024 | 8 | — |
| +10 | K240062 | ARVIS® Shoulder | Insight Medical Systems, Inc. | 2024 | 1 | — |
| +10 | K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation… | Paragon 28, Inc. | 2023 | 1 | — |
| +10 | K232413 | Fusion Robotic Navigation System | Alphatec Spine, Inc. | 2023 | 2 | — |
| +10 | K220072 | Sinobot X1 | Sinovation (Beijing) Medical Technology Co., Ltd. | 2023 | 0 | — |
| +10 | K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | 2023 | 5 | — |
| +10 | K223837 | SPIRA®-C Integrated Fixation System | Camber Spine Technologies | 2023 | 0 | — |
| +10 | K220830 | TrueBalance™ Surgical System | These Three Medical, LLC | 2022 | 0 | — |
| +10 | K221362 | Omni Foot and Ankle Plating System | Exremity Medical, LLC | 2022 | 0 | — |
| +10 | K214065 | ROSA ONE Brain application | Medtech S.A.S | 2022 | 1 | — |
| +10 | K201255 | TSolution® One Total Knee Application | THINK Surgical, Inc. | 2020 | 3 | — |
| +10 | K193614 | FINE Osteotomy around the knee | Bodycad Laboratories, Inc. | 2020 | 4 | — |
| +10 | K192163 | TTC Phantom® Intramedullary Nail System | Paragon 28, Inc. | 2020 | 6 | — |
| +10 | K193135 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2019 | 4 | — |
| +10 | K192592 | Axis Plating System | Extremity Medical, LLC | 2019 | 0 | — |
| +10 | K191998 | Mako Total Hip Application, Mako Total Knee Application | Mako Surgical Corp. | 2019 | 6 | — |
| +10 | K191782 | TTC Phantom Intramedullary Nail System | Paragon 28, Inc. | 2019 | 6 | — |
| +10 | K180271 | NAVIO™ Surgical System (NAVIO system) | Blue Belt Technologies, Inc. | 2018 | 16 | — |
| +11 | K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | 2026 | 0 | — |
| +11 | K261882 | Pisces-SC Standalone Cervical Interbody System | Osseus Fusions Systems, LLC | 2026 | 0 | — |
| +11 | K261205 | SPINEART Navigation Instrument System | Spineart SA | 2026 | 0 | — |
| +11 | K262094 | E3D™-C Interbody System | Evolution Spine | 2026 | 0 | — |
| +11 | K260036 | NeckTune™ 3D SA Cervical Cage | Medyssey Co, Ltd. | 2026 | 0 | — |
| +11 | K254105 | Hive™ Standalone Cervical System and Hive™ C Interbody System | NanoHive Medical, LLC | 2026 | 0 | — |
| +11 | K260038 | E3D™-C Interbody System | Evolution Spine | 2026 | 1 | — |
| +11 | K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | 2026 | 1 | — |
| +11 | K251314 | Rosa® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2025 | 0 | — |
| +11 | K251850 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2025 | 1 | — |
| +11 | K242933 | SPINEART Navigation Instrument System | Spineart SA | 2025 | 2 | — |
| +11 | K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar… | Carlsmed, Inc. | 2025 | 3 | — |
| +11 | K243950 | ARVIS® Shoulder | Kico Knee Innovation Company Pty, Ltd. | 2025 | 0 | 2 |