Rod, Fixation, Intramedullary And Accessories
FDA product code HSB · Class II (moderate risk) · 21 CFR 888.3020 · Orthopedic
530510(k) clearances
0PMA approvals
569recalls
Implantimplanted device
Manufacturers
- Howmedica Osteonics Corp. 39
- Howmedica Corp. 26
- Synthes (Usa) 23
- Zimmer, Inc. 23
- Nuvasive Specialized Orthopedics, Inc. 18
- Ellipse Technologies, Inc. 15
- Advanced Orthopaedic Solutions, Inc. 15
- Orthofix Srl 14
- Stryker Corporation 12
- Smith & Nephew, Inc. 11
- DePuy Orthopaedics, Inc. 9
- Applied Osteo Systems, Inc. 9
- Acu Med, Inc. 9
- Paragon 28, Inc. 8
- Biomet, Inc. 8
- Stryker Trauma AG 7
- Pega Medical, Inc. 7
- Depuy, Inc. 6
- Disco-O-Tech Medical Technologies, Ltd. 6
- Biodynamic Technologies, Inc. 6
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261481 | Pangea Femur Reconstruction SystemHSB · Traditional | Stryker GmbH | 06/29/2026SE |
| K261651 | Precice Max System and Precice Ankle Salvage SystemHSB · Special | NuVasive Specialized Orthopedics | 06/18/2026SE |
| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional | Suzhou and Science & Technology Development Corp. | 06/18/2026SE |
| K253155 | Fule Metallic Lockable Intramedullary Nail SystemsHSB · Traditional | Beijing Fule Science & Technology Development… | 06/17/2026SE |
| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/16/2026SE |
| K260146 | Fitbone® Transport and Lengthening SystemHSB · Traditional | Orthofix Srl | 05/19/2026SE |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional | Orthofix Srl | 05/08/2026SE |
| K261043 | AUTOBAHN Nailing SystemHSB · Special | Globus Medical, Inc. | 04/24/2026SE |
| K252016 | Arthrex Humeral NailsHSB · Traditional | Arthrex, Inc. | 03/20/2026SE |
| K252961 | Fusion FibFix NailHSB · Traditional | Fusion Orthopedics USA, LLC | 03/18/2026SE |
| K253566 | Affixus Retrograde Femoral Nailing SystemHSB · Traditional | Zimmer, Inc. | 03/12/2026SE |
| K253517 | Reselute Tibial NailHSB · Traditional | Reselute, Inc. | 03/10/2026SE |
| K253591 | Phantom® Hindfoot TTC/TC Nail SystemHSB · Traditional | Paragon 28, Inc. | 03/05/2026SE |
| K252196 | Arthrex FibuLock Nail SystemHSB · Traditional | Arthrex, Inc. | 03/05/2026SE |
| K252025 | Active Intramedullary (AIM) Tibial Nail SystemHSB · Traditional | Satori Orthopaedics, Inc. | 03/04/2026SE |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemHSB · Traditional | Stryker GmbH | 02/03/2026SE |
| K253749 | Affixus® Natural Nail® Proximal Humeral SystemHSB · Special | Zimmer Switzerland Manufacturing GmbH | 12/12/2025SE |
| K252826 | ARIX Femur Nail SystemHSB · Traditional | Jeil Medical Corporation | 12/10/2025SE |
| K250197 | Estremo Fibular NailHSB · Traditional | Citieffe S.R.L. | 10/17/2025SE |
| K250628 | DynaNail TTC Fusion SystemHSB · Traditional | MedShape, Inc. | 09/12/2025SE |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemHSB · Traditional | Stryker GmbH | 08/20/2025SE |
| K250163 | T2 Alpha Femur Retrograde Nailing SystemHSB · Traditional | Stryker GmbH | 08/13/2025SE |
| K250622 | Succession AFN SystemHSB · Traditional | Ortho Solutions UK , Ltd. | 08/07/2025SE |
| K251850 | Phantom® Hindfoot TTC/TC Nail SystemHSB · Special | Paragon 28, Inc. | 07/14/2025SE |
| K250559 | GMReis Fibula Nail SystemHSB · Traditional | Gm Dos Reis Industria E Comercio | 06/12/2025SE |
| K242247 | ARIX Femur Nail SystemHSB · Traditional | Jeil Medical Corporation | 04/22/2025SE |
| K250112 | FitboneTM TrochantericHSB · Traditional | Orthofix Srl | 04/10/2025SE |
| K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurHSB · Special | OrthoPediatrics Corp. | 04/01/2025SE |
| K241983 | Fassier-Duval Telescoping IM SystemHSB · Traditional | Orthopediatrics Canada Ulc Dba Pega Medical | 02/21/2025SE |
| K243907 | Affixus Tibial Nailing System - 4mm screwsHSB · Traditional | Zimmer, Inc. | 02/12/2025SE |
| K243890 | Arthrex Intramedullary NailsHSB · Special | Arthrex, Inc. | 01/13/2025SE |
| K243364 | TRIGEN META-TAN Trochanteric Antegrade NailHSB · Traditional | Smith & Nephew, Inc. | 12/09/2024SE |
| K241484 | Atlas Humeral Nail SystemHSB · Traditional | Orthopedic Designs North America, Inc. (Odi-Na) | 11/05/2024SE |
| K241651 | Affixus Tibial and Antegrade Femoral Nailing SystemHSB · Traditional | Zimmer, Inc. | 09/26/2024SE |
| K234128 | Phantom Fibula Nail SystemHSB · Traditional | Paragon 28, Inc. | 08/22/2024SE |
| K230071 | Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…HSB · Traditional | Tdm Co., Ltd. | 08/22/2024SE |
| K233696 | DePuy Synthes Retrograde Femoral Nail Advanced SystemHSB · Traditional | DePuy Synthes | 08/01/2024SE |
| K233867 | Fitbone TrochantericHSB · Traditional | Orthofix Srl | 06/18/2024SE |
| K232648 | RODEO Telescopic NailHSB · Traditional | Orthofix Srl | 05/03/2024SE |
| K233910 | Vertex Hip Fracture Nailing SystemHSB · Traditional | Orthoxel Dac | 04/04/2024SE |
| K232169 | FITBONE® Transport and Lengthening SystemHSB · Traditional | Orthofix Srl | 03/22/2024SE |
| K233134 | I.T.S. INS Proximal Femur NailHSB · Traditional | I.T.S. GmbH | 02/12/2024SE |
| K234075 | Flow-NailHSB · Special | Flow-Fx, LLC | 02/05/2024SE |
| K231343 | Redemption Duo Hindfoot Nail SystemHSB · Traditional | Vilex, LLC | 01/30/2024SE |
| K232267 | Precice Max SystemHSB · Traditional | Nuvasive Specialized Orthopedics, Incorporated | 12/15/2023SE |
| K230352 | Tornier Humeral Nail and Tornier Long Humeral NailHSB · Traditional | Tornier, Inc. | 10/31/2023SE |
| K230765 | Precice Ankle Salvage SystemHSB · Traditional | Nuvasive Specialized Orthopedics, Inc. | 08/29/2023SE |
| K231266 | Pediatric Nailing Platform TibiaHSB · Traditional | OrthoPediatrics Corp. | 08/21/2023SE |
| K231114 | Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…HSB · Traditional | Zimmer Switzerland Manufacturing GmbH | 08/09/2023SE |
| K230257 | Arthrex Intramedullary NailsHSB · Traditional | Arthrex, Inc. | 07/17/2023SE |
| K230456 | SGM Femoral Nail SystemHSB · Traditional | Changzhou Geasure Medical Apparatus and… | 06/30/2023SE |
| K230512 | Gamma4 SystemHSB · Traditional | Stryker GmbH | 06/09/2023SE |
| K220234 | Precice Intramedullary Limb Lengthening SystemHSB · Traditional | Nuvasive Specialized Orthopedics, Inc. | 03/15/2023SE |
| K221621 | Pro-X1 Trochanteric Nailing SystemHSB · Traditional | X-Bolt Orthopedics | 03/06/2023SE |
| K221084 | Dyna Locking Trochanteric NailHSB · Special | Innosys | 03/03/2023SE |
| K221221 | Advanced Intramedullary Nail SystemHSB · Traditional | Double Medical Technology, Inc. | 12/21/2022SE |
| K221031 | Arthrex DualCompression Hindfoot Fusion Nail Implant SystemHSB · Traditional | Arthrex, Inc. | 12/20/2022SE |
| K221021 | Femoral Trochanteric Nail System NeonailHSB · Traditional | Neoortho Produtos Ortopédicos S/A | 12/06/2022SE |
| K222390 | Flex-Thread Ulna Intramedullary Nail SystemHSB · Traditional | Flower Orthopedics Corporation Dba Conventus… | 11/21/2022SE |
| K222309 | Gamma4 SystemHSB · Traditional | Stryker GmbH | 11/15/2022SE |
| K210980 | Smith & Nephew Intramedullary Nail SystemsHSB · Traditional | Smith & Nephew, Inc. | 11/14/2022SE |
| K221489 | Artemis Proximal Femoral Nail SystemHSB · Traditional | Glw, Inc. | 10/27/2022SE |
| K220659 | AUTOBAHN(R) EVO Femoral NailsHSB · Traditional | Globus Medical, Inc. | 09/09/2022SE |
| K220679 | Pediatric Nailing Platform FemurHSB · Traditional | OrthoPediatrics Corp. | 07/20/2022SE |
| K221115 | Flow-NailHSB · Special | Flow-Fx, LLC | 05/13/2022SE |
| K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemHSB · Traditional | Stryker GmbH | 02/11/2022SE |
| K203811 | GPC Intraheal Intramedullary Nailing SystemHSB · Traditional | Gpc Medical Limited | 02/10/2022SE |
| K211086 | The Progen Trochanteric Nail SystemHSB · Traditional | Ortho Development Corporation | 12/21/2021SE |
| K212030 | Flex-Thread Distal Fibula lntramedullary Nail SystemHSB · Special | Flower Orthopedics Corporation Dba Conventus… | 07/23/2021SE |
| K201147 | Elos® Intramedullary Nailing SystemHSB · Traditional | Intrauma S.P.A | 07/19/2021SE |
| K210869 | Phantom Hindfoot TTC/TC Nail SystemHSB · Traditional | Paragon 28, Inc. | 06/28/2021SE |
| K211292 | Fassier-Duval Telescopic IM SystemHSB · Special | Pega Medical, Inc. | 05/26/2021SE |
| K210285 | Adaptable Ortho Innovations Intramedullary Nail SystemHSB · Traditional | Adaptable Ortho Innovations, LLC | 03/18/2021SE |
| K203819 | T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…HSB · Traditional | Stryker GmbH | 02/26/2021SE |
| K201379 | Artemis Proximal Femoral Nail SystemHSB · Traditional | Glw, Inc. | 02/19/2021SE |
| K203399 | Fitbone(R) TaaHSB · Traditional | Wittenstein Intens GmbH | 02/17/2021SE |
| K202858 | Flex-ThreadTM Distal Fibula Intramedullary Nail SystemHSB · Traditional | Conventus Orthopaedics, LLC | 01/22/2021SE |
| K202348 | External Remote Controller ERC 4PHSB · Traditional | Nuvasive Specialized Orthopedics, Inc. | 12/22/2020SE |
| K202935 | Syntec Femoral Nail Extended SystemHSB · Special | Syntec Scientific Corporation | 10/28/2020SE |
| K200127 | TELEGRAPH® EVOLUTION Humeral Nailing SystemHSB · Traditional | FH Industrie | 10/01/2020SE |
| K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for…HSB · Traditional | Synthes (USA) Products, LLC | 09/23/2020SE |
| K200430 | Precice® Ankle Salvage SystemHSB · Traditional | Nuvasive Specialized Orthopedics, Inc. | 09/16/2020SE |
| K202099 | AOS Galileo Trochanteric Nail SystemHSB · Special | Advanced Orthopaedic Solutions, Inc. | 08/28/2020SE |
| K201830 | ANSER Clavicle PinHSB · Traditional | BAAT Medical Products B.V. | 08/27/2020SE |
| K201567 | Precice® Bone Transport SystemHSB · Traditional | Nuvasive Specialized Orthopedics, Inc. | 08/10/2020SE |
| K200869 | Gamma3 SystemHSB · Traditional | Stryker Trauma GmbH | 07/22/2020SE |
| K201227 | Phantom® Hindfoot TTC/TC Nail SystemHSB · Special | Paragon 28, Inc. | 07/17/2020SE |
| K200880 | T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…HSB · Traditional | Stryker GmbH | 07/01/2020SE |
| K192710 | The Simple Locking Intramedullary (Slim) SystemHSB · Traditional | Pega Medical, Inc. | 06/24/2020SE |
| K193617 | Precice® ScrewsHSB · Traditional | Nuvasive Specialized Orthopedics, Inc. | 05/08/2020SE |
| K193016 | PRECICE Bone Transport SystemHSB · Traditional | Nuvasive Specialized Orthopedics, Inc. | 05/08/2020SE |
| K200814 | Affixus(R) Natural Nail(R) System Humeral NailHSB · Special | Zimmer GmbH | 04/28/2020SE |
| K193308 | T2 Alpha Tibia Nailing System, IMN Screws SystemHSB · Traditional | Stryker Trauma GmbH | 02/23/2020SE |
| K192163 | TTC Phantom® Intramedullary Nail SystemHSB · Traditional | Paragon 28, Inc. | 01/31/2020SE |
| K183666 | EBA One Nailing SystemHSB · Traditional | Citieffe S.R.L. | 11/14/2019SE |
| K192312 | Zimmer Natural Nail System Cephalomedullary NailsHSB · Special | Zimmer GmbH | 10/11/2019SE |
| K190321 | Pediatric Nailing PlatformFemurHSB · Special | OrthoPediatrics Corp. | 10/09/2019SE |
| K191336 | PRECICE SystemHSB · Traditional | Nuvasive Specialized Orthopedics, Inc. | 09/26/2019SE |
| K191782 | TTC Phantom Intramedullary Nail SystemHSB · Special | Paragon 28, Inc. | 09/06/2019SE |
| K191617 | Syntec Tibial Nail SystemHSB · Traditional | Syntec Scientific Corporation | 09/03/2019SE |
| K191598 | AOS ES Retrograde Femoral NailHSB · Special | Advanced Orthopaedic Solutions, Inc. | 07/18/2019SE |
| K191238 | Zimmer Guide Wire DevicesHSB · Traditional | Zimmer, Inc. | 07/05/2019SE |
| K191271 | T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…HSB · Special | Stryker Trauma GmbH | 06/11/2019SE |
| K181296 | Syntec Femoral Nail SystemHSB · Traditional | Syntec Scientific Corporation | 04/11/2019SE |
| K182170 | PRECICE® BONE TRANSPORT SystemHSB · Traditional | Nuvasive Specialized Orthopedics, Inc. | 02/05/2019SE |
| K181540 | Estremo Citieffe Nailing SystemHSB · Traditional | Citieffe S.R.L. | 01/16/2019SE |
| K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemHSB · Traditional | Paragon 28, Inc. | 01/14/2019SE |
| K183162 | Affixus Hip Fracture NailHSB · Special | Biomet, Inc. | 12/14/2018SE |
| K181827 | Affixus Natural Nail System Humeral NailHSB · Traditional | Zimmer GmbH | 12/14/2018SE |
| K181639 | Panta 2 Arthrodesis Nail SystemHSB · Special | Integra LifeSciences Corporation | 11/02/2018SE |
| K181026 | OsteoBridge IDSF SystemHSB · Special | Merete GmbH | 10/17/2018SE |
| K181640 | X-BOLT Hip Fracture Fixation SystemHSB · Traditional | X-Bolt Orthopaedics | 10/12/2018SE |
| K172830 | Double Medical Femoral Nail SystemHSB · Traditional | Double Medical Technology, Inc. | 08/24/2018SE |
| K181184 | OIC Intramedullary Nail SystemHSB · Special | The Orthopaedic Implant Company | 07/27/2018SE |
| K173656 | Arthrex FibuLock NailHSB · Special | Arthrex, Inc. | 07/26/2018SE |
| K181375 | Apex Femoral Nailing SystemHSB · Traditional | Orthoxel | 07/17/2018SE |
| K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…HSB · Traditional | Stryker Trauma GmbH | 06/06/2018SE |
| K172583 | OrthoPediatrics PediNail Intramedullary PlatformHSB · Traditional | Orthopediatrics, Inc. | 05/10/2018SE |
| K172699 | Agile NailHSB · Traditional | Orthofix Srl | 04/23/2018SE |
| K180503 | PRECICE STRYDE SystemHSB · Special | Nuvasive Specialized Orthopedics, Inc. | 04/03/2018SE |
| K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemHSB · Traditional | In2bones Sas | 03/15/2018SE |
| K173255 | Talon DistalFix Humeral NailHSB · Traditional | Orthopedic Designs North America, Inc. | 02/22/2018SE |
| K172189 | Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt &…HSB · Traditional | Truemed Group, LLC | 01/16/2018SE |
| K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemHSB · Traditional | Stryker Trauma GmbH | 01/12/2018SE |
| K171108 | AUTOBAHN Nailing SystemHSB · Traditional | Globus Medical, Inc. | 12/29/2017SE |
| K173652 | Piccolo Composite Nailing SystemHSB · Special | CarboFix Orthopedics , Ltd. | 12/28/2017SE |
| K170972 | Apex Tibial Nailing SystemHSB · Traditional | Orthoxel | 12/20/2017SE |
| K173458 | ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemHSB · Special | Orthofix Srl | 12/07/2017SE |
| K173129 | PRECICE SystemHSB · Special | Nuvasive Specialized Orthopedics, Inc. | 12/01/2017SE |
| K172157 | DePuy Synthes Femoral Recon Nail SystemHSB · Traditional | Synthes (USA) Products, LLC | 11/14/2017SE |
| K171376 | DynaNail TTC Fusion SystemHSB · Traditional | MedShape, Inc. | 11/02/2017SE |
| K172943 | Flex-Thread Fibula Pin SystemHSB · Traditional | Intrafuse, LLC | 10/30/2017SE |
| K163653 | NOVOS-NAIL Limb Lengthening System (LLS)HSB · Traditional | Smith & Nephew | 10/13/2017SE |
| K172628 | PRECICE SystemHSB · Traditional | Nuvasive Specialized Orthopedics, Inc. | 09/25/2017SE |
| K163627 | Shotel Ankle Arthrodesis Nail SystemHSB · Traditional | Biopro, Inc. | 09/14/2017SE |
| K172061 | PRECICE UNYTE SystemHSB · Traditional | Nuvasive Specialized Orthopedics, Inc. | 08/24/2017SE |
| K172114 | Zimmer Natural Nail SystemHSB · Special | Zimmer, Inc. | 08/10/2017SE |
| K163589 | SIGN IM NailHSB · Traditional | Sign Fracture Care International | 07/20/2017SE |
| K170169 | PRECICE Intramedullary Limb Lengthening SystemHSB · Traditional | Nuvasive Specialized Orthopedics, Inc. | 06/09/2017SE |
| K161327 | Syntec Humeral Nail SystemHSB · Traditional | Syntec Scientific Corporation | 06/08/2017SE |
| K162927 | PRECICE UNYTE CoCr SystemHSB · Traditional | Nuvasive Specialized Orthopedics, Inc. | 04/06/2017SE |
| K163488 | Flex-Thread Clavicle Pin SystemHSB · Traditional | Intrafuse, LLC | 03/20/2017SE |
| K170346 | PRECICE Intramedullary Limb Lengthening SystemHSB · Traditional | Nuvasive Specialized Orthopedics, Inc. | 03/07/2017SE |
| K161371 | Sonoma Fifth Metatarsal Repair SystemHSB · Traditional | Sonoma Orthopedic Products, Inc. | 02/24/2017SE |
| K163368 | Fitbone TaaHSB · Traditional | Wittenstein Intens GmbH | 01/26/2017SE |
| K163014 | AOS Small Bone Nailing SystemHSB · Traditional | Advanced Orthopaedic Solutions, Inc. (Aos) | 01/24/2017SE |
| K161466 | ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemHSB · Traditional | Orthofix Srl | 01/24/2017SE |
| K161264 | TRIGEN Low Profile Bone ScrewsHSB · Special | Smith & Nephew, Inc. | 11/23/2016SE |
| K160545 | Gap Endo-Exo Medullary SystemHSB · Traditional | Pega Medical, Inc. | 11/23/2016SE |
| K161254 | Renovo Life Small Bone IM Nail SystemHSB · Traditional | Renovo Life, LLC | 11/07/2016SE |
| K160167 | DePuy Synthes TFNA Augmentation SystemHSB · Traditional | Synthes (USA) Products, LLC | 09/26/2016SE |
| K160325 | PRECICE Intramedullary Limb Lengthening SystemHSB · Traditional | Ellipse Technologies, Inc. | 04/04/2016SE |
| K160267 | PRECICE Trauma Nail SystemHSB · Traditional | Ellipse Technologies, Incorporated | 03/31/2016SE |
| K160069 | Sonoma Fibula Repair SystemHSB · Traditional | Sonoma Orthopedics Products, Inc. | 03/10/2016SE |
| K153536 | Piccolo Composite® Nailing SystemHSB · Special | CarboFix Orthopedics , Ltd. | 01/06/2016SE |
| K152370 | PRECICE Trauma Nail SystemHSB · Special | Ellipse Technologies, Incorporated | 12/22/2015SE |
| K151062 | WASTON Metallic Intramedullary Nail SystemHSB · Traditional | Changzhou Waston Medical Appliance Co., Ltd. | 12/17/2015SE |
| K150769 | Cardinal Health Trochanteric IM Nail SystemHSB · Traditional | Cardinalhealth | 12/14/2015SE |
| K152757 | SIGN Hip Construct (SHC)HSB · Traditional | Sign Fracture Care International | 11/13/2015SE |
| K152295 | Talon DistalFix Antegrade/Retrograde Femoral NailHSB · Traditional | Orthopedic Designs North America, Inc. | 11/03/2015SE |
| K151456 | Small Bone Nail ImplantHSB · Traditional | Vilex IN Tennessee, Inc. | 10/29/2015SE |
| K143245 | GPC Intramedullary Nailing SystemsHSB · Traditional | Gpc Medical Limited | 09/30/2015SE |
| K151010 | Piccolo Composite Nailing SystemHSB · Traditional | CarboFix Orthopedics , Ltd. | 07/28/2015SE |
| K143355 | The Simple Locking IntraMedullary (SLIM) SystemHSB · Traditional | Pega Medical, Inc. | 07/10/2015SE |
| K150655 | OIC Intramedullary Nail SystemHSB · Traditional | Orthopaedic Implant Company | 07/09/2015SE |
| K151131 | PRECICE Intramedullary Limb Lengthening SystemHSB · Special | Ellipse Technologies, Incorporated | 06/19/2015SE |
| K150867 | Affixus Tibial Nailing SystemHSB · Traditional | Biomet, Inc. | 06/10/2015SE |
| K143204 | AOS Clavicle Intramedullary DeviceHSB · Traditional | Advanced Orthopaedic Solutions, Inc. | 06/03/2015SE |
| K143321 | ITST Intertrochanteric/Subtrochanteric Fixation SystemHSB · Traditional | Zimmer, Inc. | 05/29/2015SE |
| K150471 | CalcaNail Orthopedic Arthrodesis NailHSB · Traditional | Fournitures Hospitalieres Industrie | 05/22/2015SE |
| K150463 | CalcaNail Orthopedic NailHSB · Traditional | Fournitures Hospitalieres Industrie | 05/22/2015SE |
| K150656 | PRECICE Intramedullary Limb Lengthening SystemHSB · Special | Ellipse Technologies, Incorporated | 04/23/2015SE |
| K150073 | MICRONAIL Distal Radius SystemHSB · Special | Wrightmedicaltechnologyinc | 02/10/2015SE |
| K142451 | OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemHSB · Traditional | Merete Medical GmbH | 02/09/2015SE |
| K143276 | Acumed Small Bone IM Nail SystemHSB · Traditional | Acumed, LLC | 02/05/2015SE |
| K142945 | Sonoma Fibula Repair SystemHSB · Traditional | Sonoma Orthopedic Products, Inc. | 01/22/2015SE |
| K142599 | PRECISE Trauma Nail SystemHSB · Traditional | Ellipse Technologies, Incorporated | 01/16/2015SE |
| K141571 | Orthofix Ankle Hindfoot Nailing SystemHSB · Traditional | Orthofix Srl | 11/12/2014SE |
| K133166 | Ins Hilden Tibial ArzztHSB · Traditional | Truemed Group, LLC | 11/06/2014SE |
| K142602 | VALOR Hindfoot Fusion Nail SystemHSB · Special | Wrightmedicaltechnologyinc | 10/22/2014SE |
| K142281 | Zimmer M/Dn Intramedullary Fixation SystemHSB · Traditional | Zimmer, Inc. | 10/22/2014SE |
| K141739 | Residual Limb Lengthening SystemHSB · Traditional | Ellipse Technologies, Inc. | 10/07/2014SE |
| K141347 | Emerge Medical Im Nail SystemHSB · Traditional | Emerge Medical | 10/02/2014SE |
| K141103 | Intramedullary Nail and Screws-NeonailHSB · Traditional | Neoortho Produtos Ortopedicos S/A | 09/23/2014SE |
| K141228 | Aos 6.5MM Captured, Fully Threaded Cancellous ScrewHSB · Traditional | Advanced Orthopaedic Solutions, Inc. | 07/08/2014SE |
| K140601 | Flow-NailHSB · Traditional | Flow-Fx, LLC | 07/02/2014SE |
| K141447 | Precice Trauma Nail SystemHSB · Special | Ellipse Technologies, Inc. | 06/30/2014SE |
| K131609 | Double Engine Intrameddullary Nail SystemHSB · Traditional | Xiamen Double Engine Medical Material Co., Ltd. | 05/21/2014SE |
| K141023 | Precice Intramedullary Limb Lengthening SystemHSB · Special | Ellipse Technologies, Inc. | 05/20/2014SE |
| K131984 | Synthes Synsonic Ulna NailHSB · Traditional | Synthes (Usa) | 03/31/2014SE |
| K132078 | Metallic Intramedullary Nail SystemHSB · Traditional | Tianjin Walkman Biomaterial Co., Ltd. | 03/19/2014SE |
| K133104 | Van Hip Fracture SystemHSB · Traditional | Epix Orthopaedic, Corp. | 03/10/2014SE |
| K132945 | Cfn-Cannulated Femur Nail, Ctn-Cannulated Tibia Nail, Chn-Cannulated Humeral NailHSB · Traditional | I.T.S. GmbH | 03/07/2014SE |
| K131548 | Synthes Trochanteric Fixation Nail - Advanced SystemHSB · Traditional | Synthes (USA) Products, LLC | 02/28/2014SE |
| K131490 | Ellipse Precice Intramedullary Limb Lengthening SystemHSB · Traditional | Ellipse Technologies, Inc. | 01/23/2014SE |
| K132830 | Distalock Tibial Im Nail SystemHSB · Traditional | Dgimed Ortho, Inc. | 01/06/2014SE |
| K133081 | Trochanteric Nails and Es Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…HSB · Special | Advanced Orthopaedic Solutions, Inc. | 12/31/2013SE |
| K132428 | IdealHSB · Traditional | Jiangsu Ideal Medical Science & Technology Co., LT | 12/20/2013SE |
| K133289 | Precice Intramedullary Limb Lengthening SystemHSB · Special | Ellipse Technologies, Inc. | 12/09/2013SE |
| K133376 | Aequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left and RightHSB · Special | Tornier, Inc. | 12/05/2013SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2456-2026 Class II | TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision… | Smith & Nephew, Inc. | 03/16/2026Open, Classified |
| Z-0983-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | Zimmer, Inc. | 12/02/2025Open, Classified |
| Z-0982-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | Zimmer, Inc. | 12/02/2025Open, Classified |
| Z-0981-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | Zimmer, Inc. | 12/02/2025Open, Classified |
| Z-0980-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | Zimmer, Inc. | 12/02/2025Open, Classified |
| Z-0979-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | Zimmer, Inc. | 12/02/2025Open, Classified |
| Z-0978-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | Zimmer, Inc. | 12/02/2025Open, Classified |
| Z-0977-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | Zimmer, Inc. | 12/02/2025Open, Classified |
| Z-0976-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | Zimmer, Inc. | 12/02/2025Open, Classified |
| Z-0975-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | Zimmer, Inc. | 12/02/2025Open, Classified |
| Z-0974-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | Zimmer, Inc. | 12/02/2025Open, Classified |
| Z-0973-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | Zimmer, Inc. | 12/02/2025Open, Classified |
| Z-0972-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | Zimmer, Inc. | 12/02/2025Open, Classified |
| Z-0971-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | Zimmer, Inc. | 12/02/2025Open, Classified |
| Z-0970-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | Zimmer, Inc. | 12/02/2025Open, Classified |
| Z-0969-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | Zimmer, Inc. | 12/02/2025Open, Classified |
| Z-0968-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | Zimmer, Inc. | 12/02/2025Open, Classified |
| Z-0967-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | Zimmer, Inc. | 12/02/2025Open, Classified |
| Z-0871-2026 Class II | Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-SFibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of… | Paragon 28, Inc. | 10/13/2025Open, Classified |
| Z-1914-2025 Class II | Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number:…Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail. | Stryker GmbH | 05/28/2025Open, Classified |
| Z-1940-2025 Class II | Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version… | Stryker GmbH | 05/22/2025Open, Classified |
| Z-1939-2025 Class II | Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version… | Stryker GmbH | 05/22/2025Open, Classified |
| Z-1806-2025 Class II | META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized… | Smith & Nephew, Inc. | 03/18/2025Open, Classified |
| Z-0500-2025 Class II | Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x…Due to potential issues with design, manufacturing and documentation issues related to the validation of the… | NuVasive Specialized Orthopedics, Inc. | 09/30/2024Open, Classified |
| Z-1977-2025 Class II | REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, SterileRetrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the… | Orthofix Srl | 09/24/2024Open, Classified |
| Z-1240-2024 Class II | TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and…Products not sterilized, sterility cannot be confirmed | Synthes (USA) Products LLC | 01/24/2024Open, Classified |
| Z-1239-2024 Class II | TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and…Products not sterilized, sterility cannot be confirmed | Synthes (USA) Products LLC | 01/24/2024Open, Classified |
| Z-1234-2024 Class II | 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate…Products not sterilized, sterility cannot be confirmed | Synthes (USA) Products LLC | 01/24/2024Open, Classified |
| Z-1256-2024 Class II | Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250RMedical devices distributed, prior to sterilization | Paragon 28, Inc. | 12/21/2023Open, Classified |
| Z-1255-2024 Class II | Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175LMedical devices distributed, prior to sterilization | Paragon 28, Inc. | 12/21/2023Open, Classified |
| Z-1254-2024 Class II | Phantom TTC Nail, 10.0 X 200mm, RightMedical devices distributed, prior to sterilization | Paragon 28, Inc. | 12/21/2023Open, Classified |
| Z-0074-2024 Class II | Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and…Device is breaking while in use, potential for patients to require a revision surgery. | Flower Orthopedics Corporation | 08/29/2023Open, Classified |
| Z-2444-2023 Class II | TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340…A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME… | Smith & Nephew, Inc. | 07/24/2023Open, Classified |
| Z-2443-2023 Class II | TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336…A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME… | Smith & Nephew, Inc. | 07/24/2023Open, Classified |
| Z-1248-2023 Class II | TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for…TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled… | Synthes (USA) Products LLC | 02/01/2023Open, Classified |
| Z-1247-2023 Class II | TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for…TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled… | Synthes (USA) Products LLC | 02/01/2023Open, Classified |
| Z-1246-2023 Class II | TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for…TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled… | Synthes (USA) Products LLC | 02/01/2023Open, Classified |
| Z-1036-2023 Class II | OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the…Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement | Biomet, Inc. | 11/29/2022Open, Classified |
| Z-0448-2022 Class II | Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with…Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to… | Flower Orthopedics Corporation | 11/02/2021Terminated |
| Z-0319-2022 Class II | NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model…The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use… | NuVasive Specialized Orthopedics, Inc. | 10/29/2021Open, Classified |
| Z-2171-2021 Class II | Nail Insertion Sleeve, elastic T2 Tibia SPI 8-11 (SPI Elast. Sleeve 8-11), Catalog…The devices have a different inner diameter than the diameter specified on the outer box label. | Stryker GmbH | 05/27/2021Open, Classified |
| Z-2170-2021 Class II | Nail Insertion Sleeve, elastic T2 Tibia SPI 8-13 (SPI Elast. Sleeve 8-13), Catalog…The devices have a different inner diameter than the diameter specified on the outer box label. | Stryker GmbH | 05/27/2021Open, Classified |
| Z-1793-2021 Class II | Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left…Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125… | Zimmer GmbH | 05/07/2021Terminated |
| Z-1792-2021 Class II | Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left…Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125… | Zimmer GmbH | 05/07/2021Terminated |
| Z-1351-2021 Class II | NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant…Due to not having the full complement of biological assessments for all potential patients and as a result… | Nuvasive Specialized Orthopedics Inc | 02/12/2021Open, Classified |
| Z-1350-2021 Class II | NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE…Due to not having the full complement of biological assessments for all potential patients and as a result… | Nuvasive Specialized Orthopedics Inc | 02/12/2021Open, Classified |
| Z-1349-2021 Class II | NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for…Due to not having the full complement of biological assessments for all potential patients and as a result… | Nuvasive Specialized Orthopedics Inc | 02/12/2021Open, Classified |
| Z-1325-2021 Class II | PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture…Due to complaints of adverse events potentially related to biological safety. The complaints included report… | Nuvasive Specialized Orthopedics Inc | 02/12/2021Open, Classified |
| Z-1324-2021 Class II | Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed…Due to complaints of adverse events potentially related to biological safety. The complaints included report… | Nuvasive Specialized Orthopedics Inc | 02/12/2021Open, Classified |
| Z-1323-2021 Class II | PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture…Due to complaints of adverse events potentially related to biological safety. The complaints included report… | Nuvasive Specialized Orthopedics Inc | 02/12/2021Open, Classified |