Devices descending from K002619
597 later devices reach Newgen System through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +9 | K141264 | Tensyn Band, Tensyn Fracture Plates | Dallen Medical, Inc. | 2014 | 2 | — |
| +9 | K141992 | Variax 2 System | Stryker Trauma AG | 2014 | 22 | — |
| +9 | K140792 | Salvation 3DI Plating System | Wrightmedicaltechnologyinc | 2014 | 2 | 1 |
| +9 | K122489 | Emerge Medical Solid Bone Screws | Emerge Medical | 2012 | 1 | — |
| +9 | K120409 | Piccolo Composite Plate System | CarboFix Orthopedics, Ltd. | 2012 | 11 | — |
| +9 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | 39 | — |
| +9 | K121437 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | 38 | — |
| +10 | K262963 | TMC Implant Fixation System | Treace Medical Concepts, Inc. | 2026 | 0 | — |
| +10 | K261191 | Alians Elbow S | Newclip Technics | 2026 | 0 | — |
| +10 | K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | 2026 | 0 | — |
| +10 | K252699 | CoAptix S System | University of Utah, Department of Orthopaedics | 2026 | 0 | — |
| +10 | K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | 2026 | 1 | — |
| +10 | K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Arthrex, Inc. | 2026 | 0 | — |
| +10 | K253488 | iFuse INTRA Ti™ Implant System | SI-BONE, Inc. | 2026 | 0 | — |
| +10 | K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion… | Carlsmed, Inc. | 2025 | 2 | — |
| +10 | K243943 | TriMed® Compression Screws | TriMed, Inc. | 2025 | 2 | — |
| +10 | K243995 | Arthrex Humeral Plating System and Cerclage Button | Arthrex, Inc. | 2025 | 1 | — |
| +10 | K243999 | TriMed Ankle Fixation System | TriMed, Inc. | 2025 | 2 | — |
| +10 | K241783 | FortiVy™ OsteoVy™ Lumbar IBF | Vy Spine, LLC | 2025 | 0 | — |
| +10 | K241599 | Signature Osteosynthesis Plate System | Signature Orthopaedic Pty, Ltd. | 2025 | 0 | — |
| +10 | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi… | Alphatec Spine | 2025 | 3 | — |
| +10 | K243658 | TMC Compression Implant System | Treace Medical Concepts | 2024 | 2 | — |
| +10 | K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2024 | 5 | — |
| +10 | K241128 | TDM Plate and Screw System | Tdm Co., Ltd. | 2024 | 0 | — |
| +10 | K242364 | IdentiTi™ II Interbody System | Alphatec Spine, Inc. | 2024 | 4 | — |
| +10 | K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System | Alphatec Spine, Inc. | 2024 | 1 | — |
| +10 | K241504 | iFuse TORQ TNT™ Implant System | SI-BONE, Inc. | 2024 | 0 | — |
| +10 | K241846 | E3D™-C Interbody System | Evolution Spine | 2024 | 6 | — |
| +10 | K240368 | E3D™-A Interbody System | Evolution Spine | 2024 | 7 | — |
| +10 | K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS… | Alphatec Spine, Inc. | 2024 | 5 | — |
| +10 | K234031 | Medline UNITE Ancillary Foot Recon Plating System | Medline Industires, LP | 2024 | 1 | — |
| +10 | K230507 | Zimed Distal Medial Tibial Plate and Screw System | Zimed Medikal | 2024 | 0 | — |
| +10 | K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable… | OSSIO, Ltd. | 2023 | 3 | — |
| +10 | K232504 | Calibrate CCX Interbody System | Alphatec Spine, Inc. | 2023 | 1 | 1 |
| +10 | K231649 | Intraosseous Fusion Device System | Auxano Medical, LLC | 2023 | 0 | — |
| +10 | K232097 | IdentiTi ALIF Interbody Systems | Alphatec Spine, Inc. | 2023 | 7 | 1 |
| +10 | K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System… | Stryker GmbH | 2023 | 4 | — |
| +10 | K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | Alphatec Spine, Inc. | 2023 | 7 | — |
| +10 | K230867 | Bone Bolt System | University of Utah, Department of Orthopaedics | 2023 | 0 | — |
| +10 | K223611 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2023 | 7 | — |
| +10 | K222465 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2023 | 9 | — |
| +10 | K221090 | Metal Cannulated Screw | Double Medical Technology, Inc. | 2023 | 0 | — |
| +10 | K222799 | Haymaker® Screw System | Orthocircle Spine D.B.A. OC Medical Devices | 2023 | 0 | — |
| +10 | K222967 | Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and… | Avanti Orthopaedics, Inc. | 2022 | 1 | — |
| +10 | K220319 | Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System | Stryker GmbH | 2022 | 1 | — |
| +10 | K212755 | SIGNUS SACRONAIL® Transsacral Stabilization System | Signus Medizintechnik GmbH | 2022 | 0 | — |
| +10 | K220197 | Trigon HA Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022 | 4 | — |
| +10 | K220136 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2022 | 8 | — |
| +10 | K203773 | BRM TOOL Screws | Brm Extremities Srl | 2022 | 1 | — |
| +10 | K213895 | Distal Humerus Plating System | Skeletal Dynamics, Inc. | 2022 | 0 | — |
| +10 | K212640 | Stratum® Ankle Fusion Plating System | Nextremity Solutions, Inc. | 2021 | 0 | — |
| +10 | K213036 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2021 | 7 | — |
| +10 | K203817 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2021 | 10 | — |
| +10 | K211783 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | 2021 | 2 | — |
| +10 | K210754 | Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2021 | 3 | — |
| +10 | K210658 | Volition Plating System | Ortho Solutions UK, Ltd. | 2021 | 0 | — |
| +10 | K210060 | CoLink Mfx Implant System | In2bones USA, LLC | 2021 | 1 | — |
| +10 | K202657 | Javelin Tailor's Bunion Fixation System | Nvision Biomedical Technologies, Inc. | 2020 | 1 | — |
| +10 | K202959 | PolyLock Plating System | Fusion Orthopedics, LLC | 2020 | 1 | — |
| +10 | K193660 | OSSIOfiber™ Compression Screws | OSSIO, Ltd. | 2020 | 6 | — |
| +10 | K201149 | CoLink Plating System | In2bones USA, LLC | 2020 | 0 | — |
| +10 | K200701 | Skeletal Dynamics Midshaft Humerus Plating System | Skeletal Dynamics, Inc. | 2020 | 0 | — |
| +10 | K200762 | CoLink Cfx Plating System | In2bones USA, LLC | 2020 | 1 | — |
| +10 | K191867 | ATLAS Plating System | MiRus, LLC | 2020 | 0 | — |
| +10 | K193614 | FINE Osteotomy around the knee | Bodycad Laboratories, Inc. | 2020 | 4 | — |
| +10 | K192619 | Pitkar Locked Plating System | S.H.Pitkar Orthotools Pvt., Ltd. | 2020 | 0 | — |
| +10 | K192096 | Omnia Medical Trauma Screws | Omnia Medical, LLC | 2020 | 0 | — |
| +10 | K193414 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020 | 6 | — |
| +10 | K193543 | CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System… | In2bones USA, LLC | 2020 | 0 | — |
| +10 | K192696 | TriMed ASET Foot Plating System | TriMed, Inc. | 2020 | 1 | — |
| +10 | K192645 | Trigon™ Ti Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2019 | 7 | — |
| +10 | K192504 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2019 | 10 | — |
| +10 | K190830 | TDM Screw Systems | Tdm Co., Ltd. | 2019 | 1 | — |
| +10 | K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan… | In2bones USA, LLC | 2019 | 0 | — |
| +10 | K183363 | Treace Medical Concepts (TMC) Snap-Off Screw System | Treace Medical Concepts, Inc. | 2019 | 1 | — |
| +10 | K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System | Paragon 28, Inc. | 2019 | 8 | — |
| +10 | K181820 | Medline Unite Mini Plates and Screws | Medline Industries, Inc. | 2018 | 2 | — |
| +10 | K182402 | CoLink View Plating System | In2bones USA, LLC | 2018 | 2 | — |
| +10 | K181113 | CoLink™ Afx Plating System | In2bones USA, LLC | 2018 | 14 | — |
| +10 | K180808 | Omni Foot Plating System | Extremity Medical, LLC | 2018 | 3 | — |
| +10 | K171690 | Trident Extremity Fixation System | Trident Orthopedics | 2018 | 0 | — |
| +10 | K173641 | Activ Ankle | Newclip Technics | 2018 | 3 | — |
| +10 | K171372 | Alians Elbow Locking Plating System | Newclip Technics | 2018 | 0 | — |
| +10 | K172350 | AxSOS 3 Ti | Stryker GmbH | 2017 | 17 | — |
| +10 | K172178 | Minimally Invasive Bunion Plating System | Trilliant Surgical, Ltd. | 2017 | 4 | — |
| +10 | K171510 | Footmotion Plating System | Newclip Technics | 2017 | 1 | — |
| +10 | K170771 | VariAx 2 Foot System | Stryker GmbH | 2017 | 0 | — |
| +10 | K170012 | Foot and Hand Motion | Newclip Technics | 2017 | 0 | — |
| +10 | K163425 | NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS… | Narang Medical USA Corporation | 2017 | 0 | — |
| +10 | K162439 | AxSOS 3 Ti; Stryker Plating System | Stryker GmbH | 2017 | 24 | — |
| +10 | K162829 | Medline UNITE® Ankle Fracture Plating System | Medline Industries, Inc. | 2016 | 1 | — |
| +10 | K160177 | Gridlock Ankle Plating System | Trilliant Surgical, Ltd. | 2016 | 3 | 1 |
| +10 | K160002 | Piccolo Composite (R) Distal Volar Radius Plate System | CarboFix Orthopedics, Ltd. | 2016 | 4 | — |
| +10 | K151708 | RECON system - Compression Screws | Normed Medizin-Technik GmbH | 2016 | 0 | — |
| +10 | K153531 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2016 | 11 | — |
| +10 | K151886 | Acumed Ankle and Small Fragment Base Set Update | Acumed, LLC | 2015 | 15 | — |
| +10 | K151769 | Anchorage 2 CP System | Stryker GmbH | 2015 | 0 | — |
| +10 | K143496 | Piccolo Composite Plate System | CarboFix Orthopedics, Ltd. | 2015 | 4 | — |
| +10 | K150368 | Tarsa-Link Wedge Fixation System | Life Spine | 2015 | 10 | — |
| +10 | K143092 | Tensyn Plug | Dallen Medical, Inc. | 2015 | 1 | — |