Devices descending from K831576
103 later devices reach Orthofix through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K101338 | Newfix External Fixation System | Technologia Y Diseno Industrial, S.A DE C.V | 2011 | 0 | — |
| +1 | K032427 | Fep Fixation System and Stylo Wrist Fixation System | Meridan Medical | 2003 | 2 | — |
| +1 | K023714 | Reprocessed External Fixation Device | Alliance Medical Corp. | 2003 | 1 | — |
| +1 | K981716 | External Fixation | Avanta Orthopaedics, Inc. | 1998 | 2 | — |
| +1 | K974911 | External Fixator | Avanta Orthopaedics, Inc. | 1998 | 3 | — |
| +1 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 95 | 23 |
| +2 | K241357 | XT3 System | Biodynamik, Inc. | 2025 | 1 | — |
| +2 | K200518 | Pitkar External Fixation System - Rail Mechanism | S.H.Pitkar Orthotools Pvt., Ltd. | 2020 | 2 | — |
| +2 | K182285 | PK High Tibial Osteotomy Correction System | Paonan Biotech Co., Ltd. | 2019 | 0 | — |
| +2 | K141760 | Orthofix Galaxy Wrist | Orthofix Srl | 2014 | 0 | 1 |
| +2 | K141078 | Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) | Orthofix Srl | 2014 | 32 | — |
| +2 | K132820 | Vilex Ultima External Fixation System with HA Coated Pins and Wires | Vilex, Inc. | 2014 | 5 | — |
| +2 | K122210 | Newfix External Fixation System | Tecnologia Y Diseno Industrial, S.A DE C.V | 2013 | 0 | — |
| +2 | K113770 | Orthofix Galaxy Fixation System | Orthofix Srl | 2012 | 6 | 13 |
| +2 | K101375 | Trimed X-Fix | TriMed, Inc. | 2010 | 1 | — |
| +2 | K071395 | Biomet Vision Footring System | Biomet Manufacturing Corp | 2007 | 1 | — |
| +2 | K070016 | Blue Shark | Meridan Medical | 2007 | 0 | — |
| +2 | K060403 | Pta (Progressive Tibial Alignment) | Meridian Medical | 2006 | 0 | — |
| +2 | K052196 | Vilex X-Fix | Vilex, Inc. | 2005 | 13 | — |
| +2 | K052065 | Alliance Medical Corporation Reprocessed External Fixation Devices | Alliance Medical Corp. | 2005 | 0 | — |
| +2 | K051017 | R-X-Fix External Fixator | R-X-Fix | 2005 | 1 | — |
| +2 | K010322 | Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthodyne, Inc. | 2001 | 35 | 1 |
| +3 | K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm | Biodynamik, Inc. | 2026 | 0 | — |
| +3 | K242452 | Monkey Bars Pin to Bar External Fixation System | Paragon 28, Inc. | 2024 | 0 | — |
| +3 | K200491 | Bfix Orthopedic External Fixator Systems | Aike (Shanghai) Medical Instrument Co., Ltd. | 2021 | 0 | — |
| +3 | K200123 | Accessories for the SixFix® Hexapod Fixator | Arrowhead De, LLC | 2020 | 0 | — |
| +3 | K193368 | Smart Correction System | Wishbone Medical, Inc. | 2020 | 3 | 1 |
| +3 | K202143 | Dynex Micro | Vilex, LLC | 2020 | 1 | — |
| +3 | K202054 | Dynex Ring Fixation System, Diametrix Ring Fixation System | Vilex, LLC | 2020 | 1 | — |
| +3 | K180539 | Deformity Analysis and Correction Software (DACS) and Instrumentation | Arrowhead Medical Device Technologies, LLC | 2018 | 4 | — |
| +3 | K163653 | NOVOS-NAIL Limb Lengthening System (LLS) | Smith & Nephew | 2017 | 0 | — |
| +3 | K163487 | Ultima HA Coated Half Pins and Wire | Vilex IN Tennessee, Inc. | 2017 | 4 | — |
| +3 | K151881 | X-Fix Line Additions | Vilex IN Tennessee, Inc. | 2016 | 7 | 2 |
| +3 | K150640 | RX-FIX Mini Rail External Fixator | Wrightmedicaltechnologyinc | 2015 | 0 | — |
| +3 | K143125 | Orthofix True Lok Hexapod System VI.3 | Orthofix Srl | 2014 | 26 | — |
| +3 | K142052 | Orthofix Galaxy Unyco Diaphyseal Tibia Kit | Orthofix Srl | 2014 | 2 | 1 |
| +3 | K140158 | S.E.a.L. Fracture Fusion Tube | Dne, LLC | 2014 | 0 | — |
| +3 | K122208 | External Fixator System | Christopher D. Endara | 2012 | 0 | — |
| +3 | K101997 | Ellipse Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2011 | 29 | 2 |
| +3 | K093753 | Mdpo Frame System | Mdpo, LLC | 2010 | 0 | — |
| +3 | K100857 | Fusion Medical Ring Lock System | John J Riccio | 2010 | 1 | — |
| +3 | K031875 | Inter-OS Limb Lengthener | Inter-Os Technologies | 2003 | 4 | — |
| +3 | K031219 | Modification to Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthofix, Inc. | 2003 | 30 | 1 |
| +4 | K260900 | DYNEX® External Fixation Systems | Vilex, LLC | 2026 | 0 | — |
| +4 | K252625 | The Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | 2025 | 0 | — |
| +4 | K252106 | External Fixation Mini Rail System | Paragon 28, Inc. | 2025 | 0 | — |
| +4 | K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | 2025 | 1 | — |
| +4 | K231461 | Smart Correction System (HA Half Pins) | Wishbone Medical, Inc. | 2023 | 1 | — |
| +4 | K223786 | Orthex External Fixation System | OrthoPediatrics Corp. | 2023 | 2 | — |
| +4 | K221366 | Smart Correction System Rings and Compatible HA-Coated Half Pins | Wishbone Medical, Inc. | 2022 | 1 | — |
| +4 | K212552 | Correx Software | Vilex, LLC | 2021 | 0 | — |
| +4 | K200343 | FusionFrame Ring Lock System | Glw Medical Innovation | 2020 | 0 | — |
| +4 | K192181 | PRECICE Plating System | Nuvasive Specialized Orthopedics, Inc. | 2019 | 2 | 1 |
| +4 | K190069 | SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Arrowhead De, LLC | 2019 | 3 | — |
| +4 | K173883 | External Fixation System | Life Spine, Inc. | 2018 | 0 | — |
| +4 | K170888 | Renovis S141 Lumbar Interbody Fusion System | Renovis Surgical Technologies | 2017 | 5 | — |
| +4 | K170169 | PRECICE Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | 2017 | 2 | — |
| +4 | K153233 | Galaxy UNYCO System | Orthofix Srl | 2016 | 1 | 1 |
| +4 | K152171 | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 | Orthofix Srl | 2015 | 19 | — |
| +4 | K131490 | Ellipse Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2014 | 14 | — |
| +4 | K131677 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2013 | 21 | — |
| +4 | K113219 | Ellipse Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2012 | 15 | — |
| +4 | K113695 | Ellipse Precice Trauma Nail System | Ellipse Technologies, Inc. | 2012 | 3 | 2 |
| +4 | K051162 | Generos SB Small Bone Distraction Implant | Orthonetx, Inc. | 2005 | 0 | — |
| +5 | K253764 | ENOS Software Guided External Fixation System | Disior, Ltd. | 2026 | 0 | — |
| +5 | K250472 | SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Amdt Holdings, Inc. | 2025 | 0 | — |
| +5 | K212070 | KMTI S141 Lumbar Interbody Fusion System | Kyocera Medical Technologies, Inc. | 2021 | 0 | — |
| +5 | K203399 | Fitbone (R) Taa | Wittenstein Intens GmbH | 2021 | 9 | — |
| +5 | K202348 | External Remote Controller ERC 4P | Nuvasive Specialized Orthopedics, Inc. | 2020 | 0 | — |
| +5 | K193617 | Precice® Screws | Nuvasive Specialized Orthopedics, Inc. | 2020 | 0 | — |
| +5 | K191336 | PRECICE System | Nuvasive Specialized Orthopedics, Inc. | 2019 | 1 | — |
| +5 | K181630 | Revolution External Plating System | New Standard Device Dba Metalogix | 2019 | 1 | 5 |
| +5 | K181655 | Renovis S180 Lateral Lumbar Interbody Fusion System | Renovis Surgical Technologies | 2018 | 4 | — |
| +5 | K170146 | Galaxy UNYCO System | Orthofix Srl | 2017 | 0 | — |
| +5 | K170650 | Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | Orthofix Srl | 2017 | 11 | 1 |
| +5 | K163368 | Fitbone Taa | Wittenstein Intens GmbH | 2017 | 10 | — |
| +5 | K151131 | PRECICE Intramedullary Limb Lengthening System | Ellipse Technologies, Incorporated | 2015 | 6 | 2 |
| +5 | K150656 | PRECICE Intramedullary Limb Lengthening System | Ellipse Technologies, Incorporated | 2015 | 3 | — |
| +5 | K141447 | Precice Trauma Nail System | Ellipse Technologies, Inc. | 2014 | 2 | — |
| +5 | K141023 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2014 | 9 | — |
| +5 | K133289 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2013 | 19 | — |
| +6 | K253991 | Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | Orthofix Srl | 2026 | 0 | — |
| +6 | K242771 | Tesera-k PL System and Tesera-k XL System | Kyocera Medical Technologies, Inc. | 2025 | 1 | — |
| +6 | K242861 | TrueLok Elevate | Orthofix Srl | 2024 | 3 | — |
| +6 | K233867 | Fitbone Trochanteric | Orthofix Srl | 2024 | 2 | 1 |
| +6 | K233025 | Revolution External Plating System | New Standard Device Dba Metalogix | 2024 | 0 | — |
| +6 | K232169 | FITBONE® Transport and Lengthening System | Orthofix Srl | 2024 | 2 | — |
| +6 | K220234 | Precice Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | 2023 | 3 | — |
| +6 | K202833 | Sequel External Fixation Device | Sequel Medical, Inc. | 2021 | 1 | — |
| +6 | K182007 | Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System | Renovis Surgical Technologies | 2018 | 0 | — |
| +6 | K160325 | PRECICE Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2016 | 5 | — |
| +6 | K142599 | PRECISE Trauma Nail System | Ellipse Technologies, Incorporated | 2015 | 1 | — |
| +6 | K141739 | Residual Limb Lengthening System | Ellipse Technologies, Inc. | 2014 | 0 | 2 |
| +7 | K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar… | Kyocera Medical Technologies, Inc. | 2026 | 0 | — |
| +7 | K261651 | Precice™ Max System and Precice™ Ankle Salvage System | NuVasive Specialized Orthopedics | 2026 | 0 | — |
| +7 | K260146 | Fitbone® Transport and Lengthening System | Orthofix Srl | 2026 | 0 | — |
| +7 | K253291 | Excelsior System | Blue Ocean Global | 2026 | 0 | — |
| +7 | K251862 | External Fixation Bone Distractor | Paragon 28, Inc. | 2025 | 0 | — |
| +7 | K250112 | FitboneTM Trochanteric | Orthofix Srl | 2025 | 0 | — |
| +7 | K232267 | Precice Max System | Nuvasive Specialized Orthopedics, Incorporated | 2023 | 1 | 1 |