| Pangea Femur Reconstruction System (K261481) | Stryker GmbH | 2026-06-29 |
| Precice™ Max System and Precice™ Ankle Salvage System (K261651) | NuVasive Specialized Orthopedics | 2026-06-18 |
| AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) (K253080) | Suzhou and Science & Technology Development Corp. | 2026-06-18 |
| Fule Metallic Lockable Intramedullary Nail Systems (K253155) | Beijing Fule Science & Technology Development Co., Ltd. | 2026-06-17 |
| HERA Interlocking Intramedullary Nailing System (K253046) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-06-16 |
| FITBONE® TRANSPORT AND LENGTHENING SYSTEM (K260146) | Orthofix Srl | 2026-05-19 |
| Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA (K253991) | Orthofix Srl | 2026-05-08 |
| AUTOBAHN™ Nailing System (K261043) | Globus Medical, Inc. | 2026-04-24 |
| Arthrex Humeral Nails (K252016) | Arthrex, Inc. | 2026-03-20 |
| Fusion FibFix Nail (K252961) | Fusion Orthopedics USA, LLC | 2026-03-18 |
| Affixus Retrograde Femoral Nailing System (K253566) | Zimmer, Inc. | 2026-03-12 |
| Reselute Tibial Nail (K253517) | Reselute, Inc. | 2026-03-10 |
| Phantom® Hindfoot TTC/TC Nail System (K253591) | Paragon 28, Inc. | 2026-03-05 |
| Arthrex FibuLock Nail System (K252196) | Arthrex, Inc. | 2026-03-05 |
| Active Intramedullary (AIM) Tibial Nail System (K252025) | Satori Orthopaedics, Inc. | 2026-03-04 |
| T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (K253640) | Stryker GmbH | 2026-02-03 |
| Affixus® Natural Nail® Proximal Humeral System (K253749) | Zimmer Switzerland Manufacturing GmbH | 2025-12-12 |
| ARIX Femur Nail System (K252826) | Jeil Medical Corporation | 2025-12-10 |
| Estremo Fibular Nail (K250197) | Citieffe S.R.L. | 2025-10-17 |
| DynaNail TTC Fusion System (K250628) | MedShape, Inc. | 2025-09-12 |
| T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (K251400) | Stryker GmbH | 2025-08-20 |
| T2 Alpha Femur Retrograde Nailing System (K250163) | Stryker GmbH | 2025-08-13 |
| Succession™ AFN System (K250622) | Ortho Solutions UK , Ltd. | 2025-08-07 |
| Phantom® Hindfoot TTC/TC Nail System (K251850) | Paragon 28, Inc. | 2025-07-14 |
| GMReis Fibula Nail System (K250559) | Gm Dos Reis Industria E Comercio | 2025-06-12 |
| ARIX Femur Nail System (K242247) | Jeil Medical Corporation | 2025-04-22 |
| FitboneTM Trochanteric (K250112) | Orthofix Srl | 2025-04-10 |
| Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur (K250623) | OrthoPediatrics Corp. | 2025-04-01 |
| Fassier-Duval Telescoping IM System (K241983) | Orthopediatrics Canada Ulc Dba Pega Medical | 2025-02-21 |
| Affixus Tibial Nailing System - 4mm screws (K243907) | Zimmer, Inc. | 2025-02-12 |
| Arthrex Intramedullary Nails (K243890) | Arthrex, Inc. | 2025-01-13 |
| TRIGEN META-TAN Trochanteric Antegrade Nail (K243364) | Smith & Nephew, Inc. | 2024-12-09 |
| Atlas™ Humeral Nail System (K241484) | Orthopedic Designs North America, Inc. (Odi-Na) | 2024-11-05 |
| Affixus Tibial and Antegrade Femoral Nailing System (K241651) | Zimmer, Inc. | 2024-09-26 |
| Phantom Fibula Nail System (K234128) | Paragon 28, Inc. | 2024-08-22 |
| Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System (K230071) | Tdm Co., Ltd. | 2024-08-22 |
| DePuy Synthes Retrograde Femoral Nail Advanced System (K233696) | DePuy Synthes | 2024-08-01 |
| Fitbone Trochanteric (K233867) | Orthofix Srl | 2024-06-18 |
| RODEO Telescopic Nail (K232648) | Orthofix Srl | 2024-05-03 |
| Vertex Hip Fracture Nailing System (K233910) | Orthoxel Dac | 2024-04-04 |
| FITBONE® Transport and Lengthening System (K232169) | Orthofix Srl | 2024-03-22 |
| I.T.S. INS Proximal Femur Nail (K233134) | I.T.S. GmbH | 2024-02-12 |
| Flow-Nail (K234075) | Flow-Fx, LLC | 2024-02-05 |
| Redemption Duo Hindfoot Nail System (K231343) | Vilex, LLC | 2024-01-30 |
| Precice Max System (K232267) | Nuvasive Specialized Orthopedics, Incorporated | 2023-12-15 |
| Tornier Humeral Nail and Tornier Long Humeral Nail (K230352) | Tornier, Inc. | 2023-10-31 |
| Precice Ankle Salvage System (K230765) | Nuvasive Specialized Orthopedics, Inc. | 2023-08-29 |
| Pediatric Nailing Platform Tibia (K231266) | OrthoPediatrics Corp. | 2023-08-21 |
| Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System (K231114) | Zimmer Switzerland Manufacturing GmbH | 2023-08-09 |
| Arthrex Intramedullary Nails (K230257) | Arthrex, Inc. | 2023-07-17 |
| SGM Femoral Nail System (K230456) | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | 2023-06-30 |
| Gamma4 System (K230512) | Stryker GmbH | 2023-06-09 |
| Precice Intramedullary Limb Lengthening System (K220234) | Nuvasive Specialized Orthopedics, Inc. | 2023-03-15 |
| Pro-X1™ Trochanteric Nailing System (K221621) | X-Bolt Orthopedics | 2023-03-06 |
| Dyna Locking Trochanteric Nail™ (K221084) | Innosys | 2023-03-03 |
| Advanced Intramedullary Nail System (K221221) | Double Medical Technology, Inc. | 2022-12-21 |
| Arthrex DualCompression Hindfoot Fusion Nail Implant System (K221031) | Arthrex, Inc. | 2022-12-20 |
| Femoral Trochanteric Nail System – Neonail (K221021) | Neoortho Produtos Ortopédicos S/A | 2022-12-06 |
| Flex-Thread™ Ulna Intramedullary Nail System (K222390) | Flower Orthopedics Corporation Dba Conventus Flower | 2022-11-21 |
| Gamma4 System (K222309) | Stryker GmbH | 2022-11-15 |
| Smith & Nephew Intramedullary Nail Systems (K210980) | Smith & Nephew, Inc. | 2022-11-14 |
| Artemis Proximal Femoral Nail System (K221489) | Glw, Inc. | 2022-10-27 |
| AUTOBAHN(R) EVO Femoral Nails (K220659) | Globus Medical, Inc. | 2022-09-09 |
| Pediatric Nailing Platform Femur (K220679) | OrthoPediatrics Corp. | 2022-07-20 |
| Flow-Nail (K221115) | Flow-Fx, LLC | 2022-05-13 |
| Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System (K213328) | Stryker GmbH | 2022-02-11 |
| GPC Intraheal Intramedullary Nailing System (K203811) | Gpc Medical Limited | 2022-02-10 |
| The Progen™ Trochanteric Nail System (K211086) | Ortho Development Corporation | 2021-12-21 |
| Flex-Thread™ Distal Fibula lntramedullary Nail System (K212030) | Flower Orthopedics Corporation Dba Conventus Flower | 2021-07-23 |
| Elos® Intramedullary Nailing System (K201147) | Intrauma S.P.A | 2021-07-19 |
| Phantom Hindfoot TTC/TC Nail System (K210869) | Paragon 28, Inc. | 2021-06-28 |
| Fassier-Duval Telescopic IM System (K211292) | Pega Medical, Inc. | 2021-05-26 |
| Adaptable Ortho Innovations Intramedullary Nail System (K210285) | Adaptable Ortho Innovations, LLC | 2021-03-18 |
| 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 (K203819) | Stryker GmbH | 2021-02-26 |
| Artemis Proximal Femoral Nail System (K201379) | Glw, Inc. | 2021-02-19 |
| FITBONE(R) TAA (K203399) | Wittenstein Intens GmbH | 2021-02-17 |
| Flex-ThreadTM Distal Fibula Intramedullary Nail System (K202858) | Conventus Orthopaedics, LLC | 2021-01-22 |
| External Remote Controller ERC 4P (K202348) | Nuvasive Specialized Orthopedics, Inc. | 2020-12-22 |
| Syntec Femoral Nail Extended System (K202935) | Syntec Scientific Corporation | 2020-10-28 |
| TELEGRAPH® EVOLUTION Humeral Nailing System (K200127) | FH Industrie | 2020-10-01 |
| DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm (K201346) | Synthes (USA) Products, LLC | 2020-09-23 |
| Precice® Ankle Salvage System (K200430) | Nuvasive Specialized Orthopedics, Inc. | 2020-09-16 |
| AOS Galileo™ Trochanteric Nail System (K202099) | Advanced Orthopaedic Solutions, Inc. | 2020-08-28 |
| ANSER Clavicle Pin (K201830) | BAAT Medical Products B.V. | 2020-08-27 |
| Precice® Bone Transport System (K201567) | Nuvasive Specialized Orthopedics, Inc. | 2020-08-10 |
| Gamma3 System (K200869) | Stryker Trauma GmbH | 2020-07-22 |
| Phantom® Hindfoot TTC/TC Nail System (K201227) | Paragon 28, Inc. | 2020-07-17 |
| 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 (K200880) | Stryker GmbH | 2020-07-01 |
| The Simple Locking Intramedullary (Slim) System (K192710) | Pega Medical, Inc. | 2020-06-24 |
| Precice® Screws (K193617) | Nuvasive Specialized Orthopedics, Inc. | 2020-05-08 |
| PRECICE Bone Transport System (K193016) | Nuvasive Specialized Orthopedics, Inc. | 2020-05-08 |
| Affixus(R) Natural Nail(R) System Humeral Nail (K200814) | Zimmer GmbH | 2020-04-28 |
| T2 Alpha Tibia Nailing System, IMN Screws System (K193308) | Stryker Trauma GmbH | 2020-02-23 |
| TTC Phantom® Intramedullary Nail System (K192163) | Paragon 28, Inc. | 2020-01-31 |
| EBA One Nailing System (K183666) | Citieffe S.R.L. | 2019-11-14 |
| Zimmer Natural Nail System Cephalomedullary Nails (K192312) | Zimmer GmbH | 2019-10-11 |
| Pediatric Nailing PlatformFemur (K190321) | OrthoPediatrics Corp. | 2019-10-09 |
| PRECICE System (K191336) | Nuvasive Specialized Orthopedics, Inc. | 2019-09-26 |
| TTC Phantom Intramedullary Nail System (K191782) | Paragon 28, Inc. | 2019-09-06 |
| Syntec Tibial Nail System (K191617) | Syntec Scientific Corporation | 2019-09-03 |