Devices descending from K014263
596 later devices reach Newgen/Universal Mandibular System through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +9 | K130061 | Piccolo Composite Plate System | CarboFix Orthopedics, Ltd. | 2013 | 10 | — |
| +9 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | 38 | — |
| +10 | K262098 | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | 2026 | 0 | — |
| +10 | K262344 | Large Compression Screws | TriMed, Inc. | 2026 | 0 | — |
| +10 | K261511 | Xpert Ankle | Newclip Technics | 2026 | 0 | — |
| +10 | K262094 | E3D™-C Interbody System | Evolution Spine | 2026 | 0 | — |
| +10 | K261020 | Symmetrix™ L Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026 | 0 | — |
| +10 | K260036 | NeckTune™ 3D SA Cervical Cage | Medyssey Co, Ltd. | 2026 | 0 | — |
| +10 | K260810 | Anteralign LS coverplate | Tyber Medical, LLC | 2026 | 0 | — |
| +10 | K261154 | CoLink® & CoLag® Non-Sterile Screws | In2Bones USA, LLC | 2026 | 0 | — |
| +10 | K261241 | TriMed Compression Screws | TriMed, Inc. | 2026 | 0 | — |
| +10 | K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and… | Carlsmed, Inc. | 2026 | 0 | — |
| +10 | K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO, Ltd. | 2026 | 0 | — |
| +10 | K253401 | SCRIPT™ Implant System | Globus Medical, Inc. | 2026 | 0 | — |
| +10 | K260291 | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. | 2026 | 0 | — |
| +10 | K254105 | Hive™ Standalone Cervical System and Hive™ C Interbody System | NanoHive Medical, LLC | 2026 | 0 | — |
| +10 | K260038 | E3D™-C Interbody System | Evolution Spine | 2026 | 1 | — |
| +10 | K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | 2026 | 1 | — |
| +10 | K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | 2026 | 1 | — |
| +10 | K253423 | ToeJack MIS Bunion System | Nvision Biomedical Technologies, Inc. | 2025 | 0 | — |
| +10 | K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System | Alphatec Spine | 2025 | 0 | — |
| +10 | K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | Alphatec Spine, Inc. | 2025 | 0 | — |
| +10 | K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | 2025 | 2 | — |
| +10 | K252113 | PRADO™ Lumbar Interbody Fusion System | Bethesda Medical Devices | 2025 | 0 | — |
| +10 | K251945 | TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) | TriMed, Inc. | 2025 | 1 | — |
| +10 | K251080 | IdentiTi II Cervical Interbody System | Alphatec Spine, Inc. | 2025 | 0 | — |
| +10 | K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | 2025 | 0 | — |
| +10 | K250935 | TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System… | TriMed, Inc. | 2025 | 0 | — |
| +10 | K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | Medline Industries, LP | 2025 | 0 | — |
| +10 | K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar… | Carlsmed, Inc. | 2025 | 3 | — |
| +10 | K243461 | Calibrate Interbody Systems | Alphatec Spine, Inc. | 2025 | 0 | — |
| +10 | K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies | 2024 | 1 | — |
| +10 | K242671 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2024 | 1 | — |
| +10 | K241277 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO, Ltd. | 2024 | 1 | — |
| +10 | K240126 | ProAM ALIF System | Pro Surgical, Inc. | 2024 | 2 | — |
| +10 | K233863 | TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating… | TriMed, Inc. | 2024 | 0 | — |
| +10 | K233912 | ARIX Cannulated Screw System | Jeil Medical Corporation | 2024 | 0 | — |
| +10 | K233198 | OSSIOfiber® Threaded Trimmable Fixation Nails | OSSIO, Ltd. | 2024 | 2 | — |
| +10 | K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies | 2024 | 0 | — |
| +10 | K231860 | TDM Screw System | Tdm Co., Ltd. | 2024 | 0 | — |
| +10 | K234040 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | 2024 | 0 | 2 |
| +10 | K233423 | Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System | Tyber Medical, LLC | 2023 | 2 | — |
| +10 | K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation… | Paragon 28, Inc. | 2023 | 1 | — |
| +10 | K230946 | Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression… | Trax Surgical | 2023 | 0 | — |
| +10 | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System | Stryker GmbH | 2023 | 8 | — |
| +10 | K230749 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | 2023 | 1 | — |
| +10 | K221193 | OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm | OSSIO, Ltd. | 2022 | 4 | — |
| +10 | K222820 | BRM TOOL Screws, BIOPLAN Subtalar Implant | Brm Extremities | 2022 | 0 | — |
| +10 | K223226 | Trigon™ HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022 | 0 | — |
| +10 | K211843 | PolyLock Plating System | Fusion Orthopedics | 2022 | 0 | — |
| +10 | K212378 | Arsenal Ankle Plating System | Trilliant Surgical | 2022 | 0 | — |
| +10 | K213596 | OSSIOfiber Compression Screw, 3.5mm | OSSIO, Ltd. | 2021 | 4 | — |
| +10 | K213069 | CoLink NeoFuse Plating System | In2bones USA, LLC | 2021 | 1 | — |
| +10 | K211650 | The Radian MIS Bunion System | Nvision Biomedical Technologies, Inc. | 2021 | 3 | — |
| +10 | K212487 | CoLink Vallux Plating System | In2bones USA, LLC | 2021 | 4 | — |
| +10 | K212297 | Omni Foot and Ankle Plating System | Extremity Medical, LLC | 2021 | 1 | — |
| +10 | K211290 | Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2021 | 2 | — |
| +10 | K211646 | FINE Osteotomy | Bodycad Laboratories, Inc. | 2021 | 3 | — |
| +10 | K203445 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020 | 5 | — |
| +10 | K200961 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2020 | 9 | — |
| +10 | K192163 | TTC Phantom® Intramedullary Nail System | Paragon 28, Inc. | 2020 | 6 | — |
| +10 | K192592 | Axis Plating System | Extremity Medical, LLC | 2019 | 0 | — |
| +10 | K191782 | TTC Phantom Intramedullary Nail System | Paragon 28, Inc. | 2019 | 6 | — |
| +10 | K191009 | Arsenal Plating System | Trilliant Surgical | 2019 | 2 | — |
| +10 | K191535 | CoLink® Mini Plating System | In2bones USA, LLC | 2019 | 6 | — |
| +10 | K181091 | AxSOS 3 Ti | Stryker GmbH | 2018 | 11 | — |
| +10 | K150359 | Tensyn Plug | Dallen Medical, Inc. | 2015 | 0 | — |
| +10 | K132733 | Orthohelix Syndesmosis Fixation Devices | Orthohelix Surgical Designs, Inc. | 2014 | 3 | — |
| +10 | K132774 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2013 | 3 | — |
| +10 | K132591 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2013 | 32 | — |
| +11 | K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion… | TriMed, Inc. | 2026 | 0 | — |
| +11 | K261481 | Pangea Femur Reconstruction System | Stryker GmbH | 2026 | 0 | — |
| +11 | K252254 | Osteotomy Wedge System | Sinaptic Surgical | 2025 | 0 | — |
| +11 | K251850 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2025 | 1 | — |
| +11 | K251644 | ProAM ALIF System | Pro Surgical, Inc. | 2025 | 0 | — |
| +11 | K242517 | ProAM ACDF System | Pro Surgical, Inc. | 2024 | 0 | — |
| +11 | K242436 | Proximal Humerus Fixation System | Skeletal Dynamics, Inc. | 2024 | 0 | — |
| +11 | K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2024 | 0 | — |
| +11 | K241387 | CoLink NeoFuse MIS Plating System (see attached parts list) | In2bones USA | 2024 | 0 | — |
| +11 | K241262 | Baby Gorilla/Gorilla Plating System; Monster Screw System | Paragon 28, Inc. | 2024 | 0 | — |
| +11 | K230226 | Integrity-SI® Fusion System | OsteoCentric Technologies | 2023 | 0 | — |
| +11 | K231314 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2023 | 2 | — |
| +11 | K221362 | Omni Foot and Ankle Plating System | Exremity Medical, LLC | 2022 | 0 | — |
| +11 | K201227 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2020 | 5 | — |
| +11 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | 9 | — |
| +11 | K181067 | AlignX Ankle Fusion System | Extremity Medical, LLC | 2018 | 4 | — |
| +11 | K160191 | Align Anterior Ankle Fusion Plate | Extremity Medical, LLC | 2016 | 5 | — |
| +11 | K151010 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2015 | 2 | 1 |
| +12 | K253591 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2026 | 0 | — |
| +12 | K240066 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2024 | 1 | — |
| +12 | K231887 | ARIX Ankle Distal Tibia System | Jeil Medical Corporation | 2023 | 1 | — |
| +12 | K210869 | Phantom Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2021 | 2 | 3 |
| +12 | K173652 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2017 | 0 | — |
| +12 | K153536 | Piccolo Composite® Nailing System | CarboFix Orthopedics, Ltd. | 2016 | 1 | 1 |
| +13 | K252246 | Leforte MMF System | Jeil Medical Corporation | 2026 | 0 | — |
| +13 | K240703 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2024 | 0 | — |