Devices descending from K002053
427 later devices reach Navitrak System-Optical Option, Model 900.004 through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +9 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | 9 | — |
| +9 | K200511 | ROSA ONE Brain application | Medtech S.A | 2020 | 5 | Class I |
| +9 | K200762 | CoLink Cfx Plating System | In2bones USA, LLC | 2020 | 1 | — |
| +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 | K181067 | AlignX Ankle Fusion System | Extremity Medical, LLC | 2018 | 4 | — |
| +9 | K180307 | Mazor X | Mazor Robotics, Ltd. | 2018 | 17 | — |
| +9 | K172973 | Life Spine Foot and Ankle Plating System | Life Spine, Inc. | 2017 | 0 | — |
| +9 | K172886 | Breakaway Screw System | Paragon 28 | 2017 | 4 | — |
| +9 | K172260 | Omni Foot Plating System | Extremity Medical, LLC | 2017 | 4 | — |
| +9 | K172301 | Mako Partial Knee Application | Mako Surgical Corp. | 2017 | 1 | 6 |
| +9 | K172219 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | 37 | — |
| +9 | K170693 | Phantom Small Bone Intramedullary Nail System | Paragon 28, Inc. | 2017 | 9 | — |
| +9 | K170360 | NAVIO | Blue Belt Technologies, Inc. | 2017 | 17 | — |
| +9 | K170214 | Additive Orthopaedics Locking Lattice Plate | Additive Orthopaedics, LLC | 2017 | 8 | — |
| +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 | K253401 | SCRIPT™ Implant System | Globus Medical, Inc. | 2026 | 0 | — |
| +10 | K260601 | Real Intelligence™ Cori™ | Blue Belt Technologies, Inc. | 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 | 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 | K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip… | Stryker Instruments | 2025 | 0 | — |
| +10 | K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2025 | 0 | — |
| +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 | 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 | K233154 | SkyOPS™ Orthopedic Plate System | Sky Surgical, LLC | 2023 | 1 | — |
| +10 | K231887 | ARIX Ankle Distal Tibia System | Jeil Medical Corporation | 2023 | 1 | — |
| +10 | K232413 | Fusion Robotic Navigation System | Alphatec Spine, Inc. | 2023 | 2 | — |
| +10 | K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System… | Stryker GmbH | 2023 | 4 | — |
| +10 | K231257 | Pangea Utility Plating System, Pangea Platform | Stryker GmbH | 2023 | 1 | — |
| +10 | K220072 | Sinobot X1 | Sinovation (Beijing) Medical Technology Co., Ltd. | 2023 | 0 | — |
| +10 | K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | 2023 | 5 | — |
| +10 | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System | Stryker GmbH | 2023 | 8 | — |
| +10 | K223837 | SPIRA®-C Integrated Fixation System | Camber Spine Technologies | 2023 | 0 | — |
| +10 | K220830 | TrueBalance™ Surgical System | These Three Medical, LLC | 2022 | 0 | — |
| +10 | K214065 | ROSA ONE Brain application | Medtech S.A.S | 2022 | 1 | — |
| +10 | K212297 | Omni Foot and Ankle Plating System | Extremity Medical, LLC | 2021 | 1 | — |
| +10 | K201149 | CoLink Plating System | In2bones USA, LLC | 2020 | 0 | — |
| +10 | K201255 | TSolution® One Total Knee Application | THINK Surgical, Inc. | 2020 | 3 | — |
| +10 | K193135 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2019 | 4 | — |
| +10 | K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System | Paragon 28, Inc. | 2019 | 8 | — |
| +10 | K183011 | Additive Orthopaedics Patient Specific 3D Locking Lattice Plates | Additive Orthopaedics | 2019 | 5 | — |
| +10 | K182077 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics, Ltd. | 2018 | 16 | 2 |
| +10 | K180808 | Omni Foot Plating System | Extremity Medical, LLC | 2018 | 3 | — |
| +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 | K261481 | Pangea Femur Reconstruction System | Stryker GmbH | 2026 | 0 | — |
| +11 | K260036 | NeckTune™ 3D SA Cervical Cage | Medyssey Co, Ltd. | 2026 | 0 | — |
| +11 | K252246 | Leforte MMF System | Jeil Medical Corporation | 2026 | 0 | — |
| +11 | K254105 | Hive™ Standalone Cervical System and Hive™ C Interbody System | NanoHive Medical, LLC | 2026 | 0 | — |
| +11 | K251732 | Wrist Fracture System | Met One Technologies, LLC | 2026 | 0 | — |
| +11 | K260038 | E3D™-C Interbody System | Evolution Spine | 2026 | 1 | — |
| +11 | K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | 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 | K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | 2025 | 2 | — |
| +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 |
| +11 | K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea… | Stryker GmbH | 2024 | 0 | — |
| +11 | K242264 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2024 | 7 | — |
| +11 | K240326 | Solar™ Lumbar Interbody Fusion System | Degen Medical, Inc. | 2024 | 4 | — |
| +11 | K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation… | Paragon 28, Inc. | 2023 | 1 | — |
| +11 | K231103 | ROSA ONE Brain Application | Medtech S.A.S | 2023 | 0 | — |
| +11 | K221362 | Omni Foot and Ankle Plating System | Exremity Medical, LLC | 2022 | 0 | — |
| +11 | K203040 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2020 | 2 | — |
| +11 | K200935 | Mazor X | Mazor Robotics, Ltd. | 2020 | 15 | — |
| +11 | K193614 | FINE Osteotomy around the knee | Bodycad Laboratories, Inc. | 2020 | 4 | — |
| +11 | K192163 | TTC Phantom® Intramedullary Nail System | Paragon 28, Inc. | 2020 | 6 | — |
| +11 | K192592 | Axis Plating System | Extremity Medical, LLC | 2019 | 0 | — |
| +11 | K191782 | TTC Phantom Intramedullary Nail System | Paragon 28, Inc. | 2019 | 6 | — |
| +11 | K191223 | NAVIO | Blue Belt Technologies, Inc. | 2019 | 15 | — |
| +12 | K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and… | Carlsmed, Inc. | 2026 | 0 | — |
| +12 | K254158 | SPINEART Navigation Instrument System | Spineart SA | 2026 | 1 | — |
| +12 | K251850 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2025 | 1 | — |
| +12 | K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion… | Carlsmed, Inc. | 2025 | 2 | — |
| +12 | K243285 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2024 | 6 | — |
| +12 | K241077 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2024 | 2 | — |
| +12 | K241262 | Baby Gorilla/Gorilla Plating System; Monster Screw System | Paragon 28, Inc. | 2024 | 0 | — |
| +12 | K211646 | FINE Osteotomy | Bodycad Laboratories, Inc. | 2021 | 3 | — |
| +12 | K210668 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2021 | 0 | — |
| +12 | K203005 | Mazor X | Mazor Robotics, Ltd. | 2020 | 14 | 1 |
| +12 | K201227 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2020 | 5 | — |
| +12 | K201022 | Real Intelligence Cori (Cori) | Blue Belt Technologies, Inc. | 2020 | 13 | — |
| +12 | K193120 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2020 | 14 | — |