FDA Product Code
FDA Product Code HSB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3020
510(k) Clearances — 531 records · page 1 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261345 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2026-09-24 | Traditional | PDF ↗ |
| K261481 | Pangea Femur Reconstruction System | Stryker GmbH | 2026-06-29 | Traditional | PDF ↗ |
| K261651 | Precice Max System and Precice Ankle Salvage System | NuVasive Specialized Orthopedics | 2026-06-18 | Special | PDF ↗ |
| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) | Suzhou and Science & Technology Development Corp. | 2026-06-18 | Traditional | PDF ↗ |
| K253155 | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | 2026-06-17 | Traditional | PDF ↗ |
| K253046 | HERA Interlocking Intramedullary Nailing System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-06-16 | Traditional | PDF ↗ |
| K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | Orthofix Srl | 2026-05-19 | Traditional | PDF ↗ |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | Orthofix Srl | 2026-05-08 | Traditional | PDF ↗ |
| K261043 | AUTOBAHN Nailing System | Globus Medical, Inc. | 2026-04-24 | Special | PDF ↗ |
| K252016 | Arthrex Humeral Nails | Arthrex, Inc. | 2026-03-20 | Traditional | PDF ↗ |
| K252961 | Fusion FibFix Nail | Fusion Orthopedics USA, LLC | 2026-03-18 | Traditional | PDF ↗ |
| K253566 | Affixus Retrograde Femoral Nailing System | Zimmer, Inc. | 2026-03-12 | Traditional | PDF ↗ |
| K253517 | Reselute Tibial Nail | Reselute, Inc. | 2026-03-10 | Traditional | PDF ↗ |
| K252196 | Arthrex FibuLock Nail System | Arthrex, Inc. | 2026-03-05 | Traditional | PDF ↗ |
| K253591 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2026-03-05 | Traditional | PDF ↗ |
| K252025 | Active Intramedullary (AIM) Tibial Nail System | Satori Orthopaedics, Inc. | 2026-03-04 | Traditional | PDF ↗ |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | 2026-02-03 | Traditional | PDF ↗ |
| K253749 | Affixus® Natural Nail® Proximal Humeral System | Zimmer Switzerland Manufacturing GmbH | 2025-12-12 | Special | PDF ↗ |
| K252826 | ARIX Femur Nail System | Jeil Medical Corporation | 2025-12-10 | Traditional | PDF ↗ |
| K250197 | Estremo Fibular Nail | Citieffe S.R.L. | 2025-10-17 | Traditional | PDF ↗ |
| K250628 | DynaNail TTC Fusion System | MedShape, Inc. | 2025-09-12 | Traditional | PDF ↗ |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | Stryker GmbH | 2025-08-20 | Traditional | PDF ↗ |
| K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | 2025-08-13 | Traditional | PDF ↗ |
| K250622 | Succession AFN System | Ortho Solutions UK , Ltd. | 2025-08-07 | Traditional | PDF ↗ |
| K251850 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2025-07-14 | Special | PDF ↗ |
| K250559 | GMReis Fibula Nail System | Gm Dos Reis Industria E Comercio | 2025-06-12 | Traditional | PDF ↗ |
| K242247 | ARIX Femur Nail System | Jeil Medical Corporation | 2025-04-22 | Traditional | PDF ↗ |
| K250112 | FitboneTM Trochanteric | Orthofix Srl | 2025-04-10 | Traditional | PDF ↗ |
| K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2025-04-01 | Special | PDF ↗ |
| K241983 | Fassier-Duval Telescoping IM System | Orthopediatrics Canada Ulc Dba Pega Medical | 2025-02-21 | Traditional | PDF ↗ |
| K243907 | Affixus Tibial Nailing System - 4mm screws | Zimmer, Inc. | 2025-02-12 | Traditional | PDF ↗ |
| K243890 | Arthrex Intramedullary Nails | Arthrex, Inc. | 2025-01-13 | Special | PDF ↗ |
| K243364 | TRIGEN META-TAN Trochanteric Antegrade Nail | Smith & Nephew, Inc. | 2024-12-09 | Traditional | PDF ↗ |
| K241484 | Atlas Humeral Nail System | Orthopedic Designs North America, Inc. (Odi-Na) | 2024-11-05 | Traditional | PDF ↗ |
| K241651 | Affixus Tibial and Antegrade Femoral Nailing System | Zimmer, Inc. | 2024-09-26 | Traditional | PDF ↗ |
| K230071 | Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System | Tdm Co., Ltd. | 2024-08-22 | Traditional | PDF ↗ |
| K234128 | Phantom Fibula Nail System | Paragon 28, Inc. | 2024-08-22 | Traditional | PDF ↗ |
| K233696 | DePuy Synthes Retrograde Femoral Nail Advanced System | DePuy Synthes | 2024-08-01 | Traditional | PDF ↗ |
| K233867 | Fitbone Trochanteric | Orthofix Srl | 2024-06-18 | Traditional | PDF ↗ |
| K232648 | RODEO Telescopic Nail | Orthofix Srl | 2024-05-03 | Traditional | PDF ↗ |
| K233910 | Vertex Hip Fracture Nailing System | Orthoxel Dac | 2024-04-04 | Traditional | PDF ↗ |
| K232169 | FITBONE® Transport and Lengthening System | Orthofix Srl | 2024-03-22 | Traditional | PDF ↗ |
| K233134 | I.T.S. INS Proximal Femur Nail | I.T.S. GmbH | 2024-02-12 | Traditional | PDF ↗ |
| K234075 | Flow-Nail | Flow-Fx, LLC | 2024-02-05 | Special | PDF ↗ |
| K231343 | Redemption Duo Hindfoot Nail System | Vilex, LLC | 2024-01-30 | Traditional | PDF ↗ |
| K232267 | Precice Max System | Nuvasive Specialized Orthopedics, Incorporated | 2023-12-15 | Traditional | PDF ↗ |
| K230352 | Tornier Humeral Nail and Tornier Long Humeral Nail | Tornier, Inc. | 2023-10-31 | Traditional | PDF ↗ |
| K230765 | Precice Ankle Salvage System | Nuvasive Specialized Orthopedics, Inc. | 2023-08-29 | Traditional | PDF ↗ |
| K231266 | Pediatric Nailing Platform Tibia | OrthoPediatrics Corp. | 2023-08-21 | Traditional | PDF ↗ |
| K231114 | Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System | Zimmer Switzerland Manufacturing GmbH | 2023-08-09 | Traditional | PDF ↗ |
| K230257 | Arthrex Intramedullary Nails | Arthrex, Inc. | 2023-07-17 | Traditional | PDF ↗ |
| K230456 | SGM Femoral Nail System | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | 2023-06-30 | Traditional | PDF ↗ |
| K230512 | Gamma4 System | Stryker GmbH | 2023-06-09 | Traditional | PDF ↗ |
| K220234 | Precice Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | 2023-03-15 | Traditional | PDF ↗ |
| K221621 | Pro-X1 Trochanteric Nailing System | X-Bolt Orthopedics | 2023-03-06 | Traditional | PDF ↗ |
| K221084 | Dyna Locking Trochanteric Nail | Innosys | 2023-03-03 | Special | PDF ↗ |
| K221221 | Advanced Intramedullary Nail System | Double Medical Technology, Inc. | 2022-12-21 | Traditional | PDF ↗ |
| K221031 | Arthrex DualCompression Hindfoot Fusion Nail Implant System | Arthrex, Inc. | 2022-12-20 | Traditional | PDF ↗ |
| K221021 | Femoral Trochanteric Nail System Neonail | Neoortho Produtos Ortopédicos S/A | 2022-12-06 | Traditional | PDF ↗ |
| K222390 | Flex-Thread Ulna Intramedullary Nail System | Flower Orthopedics Corporation Dba Conventus Flower | 2022-11-21 | Traditional | PDF ↗ |
| K222309 | Gamma4 System | Stryker GmbH | 2022-11-15 | Traditional | PDF ↗ |
| K210980 | Smith & Nephew Intramedullary Nail Systems | Smith & Nephew, Inc. | 2022-11-14 | Traditional | PDF ↗ |
| K221489 | Artemis Proximal Femoral Nail System | Glw, Inc. | 2022-10-27 | Traditional | PDF ↗ |
| K220659 | AUTOBAHN(R) EVO Femoral Nails | Globus Medical, Inc. | 2022-09-09 | Traditional | PDF ↗ |
| K220679 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2022-07-20 | Traditional | PDF ↗ |
| K221115 | Flow-Nail | Flow-Fx, LLC | 2022-05-13 | Special | PDF ↗ |
| K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System | Stryker GmbH | 2022-02-11 | Traditional | PDF ↗ |
| K203811 | GPC Intraheal Intramedullary Nailing System | Gpc Medical Limited | 2022-02-10 | Traditional | PDF ↗ |
| K211086 | The Progen Trochanteric Nail System | Ortho Development Corporation | 2021-12-21 | Traditional | PDF ↗ |
| K212030 | Flex-Thread Distal Fibula lntramedullary Nail System | Flower Orthopedics Corporation Dba Conventus Flower | 2021-07-23 | Special | PDF ↗ |
| K201147 | Elos® Intramedullary Nailing System | Intrauma S.P.A | 2021-07-19 | Traditional | PDF ↗ |
| K210869 | Phantom Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2021-06-28 | Traditional | PDF ↗ |
| K211292 | Fassier-Duval Telescopic IM System | Pega Medical, Inc. | 2021-05-26 | Special | PDF ↗ |
| K210285 | Adaptable Ortho Innovations Intramedullary Nail System | Adaptable Ortho Innovations, LLC | 2021-03-18 | Traditional | PDF ↗ |
| K203819 | T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System | Stryker GmbH | 2021-02-26 | Traditional | PDF ↗ |
| K201379 | Artemis Proximal Femoral Nail System | Glw, Inc. | 2021-02-19 | Traditional | PDF ↗ |
| K203399 | FITBONE(R) TAA | Wittenstein Intens GmbH | 2021-02-17 | Traditional | PDF ↗ |
| K202858 | Flex-ThreadTM Distal Fibula Intramedullary Nail System | Conventus Orthopaedics, LLC | 2021-01-22 | Traditional | PDF ↗ |
| K202348 | External Remote Controller ERC 4P | Nuvasive Specialized Orthopedics, Inc. | 2020-12-22 | Traditional | PDF ↗ |
| K202935 | Syntec Femoral Nail Extended System | Syntec Scientific Corporation | 2020-10-28 | Special | PDF ↗ |
| K200127 | TELEGRAPH® EVOLUTION Humeral Nailing System | FH Industrie | 2020-10-01 | Traditional | PDF ↗ |
| K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm | Synthes (USA) Products, LLC | 2020-09-23 | Traditional | PDF ↗ |
| K200430 | Precice® Ankle Salvage System | Nuvasive Specialized Orthopedics, Inc. | 2020-09-16 | Traditional | PDF ↗ |
| K202099 | AOS Galileo Trochanteric Nail System | Advanced Orthopaedic Solutions, Inc. | 2020-08-28 | Special | PDF ↗ |
| K201830 | ANSER Clavicle Pin | BAAT Medical Products B.V. | 2020-08-27 | Traditional | PDF ↗ |
| K201567 | Precice® Bone Transport System | Nuvasive Specialized Orthopedics, Inc. | 2020-08-10 | Traditional | PDF ↗ |
| K200869 | Gamma3 System | Stryker Trauma GmbH | 2020-07-22 | Traditional | PDF ↗ |
| K201227 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2020-07-17 | Special | PDF ↗ |
| K200880 | T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System | Stryker GmbH | 2020-07-01 | Traditional | PDF ↗ |
| K192710 | The Simple Locking Intramedullary (Slim) System | Pega Medical, Inc. | 2020-06-24 | Traditional | PDF ↗ |
| K193016 | PRECICE Bone Transport System | Nuvasive Specialized Orthopedics, Inc. | 2020-05-08 | Traditional | PDF ↗ |
| K193617 | Precice® Screws | Nuvasive Specialized Orthopedics, Inc. | 2020-05-08 | Traditional | PDF ↗ |
| K200814 | Affixus(R) Natural Nail(R) System Humeral Nail | Zimmer GmbH | 2020-04-28 | Special | PDF ↗ |
| K193308 | T2 Alpha Tibia Nailing System, IMN Screws System | Stryker Trauma GmbH | 2020-02-23 | Traditional | PDF ↗ |
| K192163 | TTC Phantom® Intramedullary Nail System | Paragon 28, Inc. | 2020-01-31 | Traditional | PDF ↗ |
| K183666 | EBA One Nailing System | Citieffe S.R.L. | 2019-11-14 | Traditional | PDF ↗ |
| K192312 | Zimmer Natural Nail System Cephalomedullary Nails | Zimmer GmbH | 2019-10-11 | Special | PDF ↗ |
| K190321 | Pediatric Nailing PlatformFemur | OrthoPediatrics Corp. | 2019-10-09 | Special | PDF ↗ |
| K191336 | PRECICE System | Nuvasive Specialized Orthopedics, Inc. | 2019-09-26 | Traditional | PDF ↗ |
| K191782 | TTC Phantom Intramedullary Nail System | Paragon 28, Inc. | 2019-09-06 | Special | PDF ↗ |
Product code HSB · Class II · Orthopedic. Data: openFDA.