Rod, Fixation, Intramedullary And Accessories

FDA product code HSB · 490 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3020
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-11-11 – 2026-09-24

HSB 2026-09-24

Pediatric Nailing Platform Femur

Applicant OrthoPediatrics Corp.

K number K261345

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HSB 2026-06-29

Pangea Femur Reconstruction System

Applicant Stryker GmbH

K number K261481

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HSB 2026-06-18

Precice™ Max System and Precice™ Ankle Salvage System

Applicant NuVasive Specialized Orthopedics

K number K261651

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HSB 2026-06-18

AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)

Applicant Suzhou and Science & Technology Development Corp.

K number K253080

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HSB 2026-06-17

Fule Metallic Lockable Intramedullary Nail Systems

Applicant Beijing Fule Science & Technology Development Co., Ltd.

K number K253155

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HSB 2026-06-16

HERA Interlocking Intramedullary Nailing System

Applicant ZheJiang Decans Medical Devices Co., Ltd.

K number K253046

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HSB 2026-05-19

FITBONE® TRANSPORT AND LENGTHENING SYSTEM

Applicant Orthofix Srl

K number K260146

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HSB 2026-05-08

Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA

Applicant Orthofix Srl

K number K253991

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HSB 2026-04-24

AUTOBAHN™ Nailing System

Applicant Globus Medical, Inc.

K number K261043

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HSB 2026-03-20

Arthrex Humeral Nails

Applicant Arthrex, Inc.

K number K252016

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HSB 2026-03-18

Fusion FibFix Nail

Applicant Fusion Orthopedics USA, LLC

K number K252961

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HSB 2026-03-12

Affixus Retrograde Femoral Nailing System

Applicant Zimmer, Inc.

K number K253566

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HSB 2026-03-10

Reselute Tibial Nail

Applicant Reselute, Inc.

K number K253517

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HSB 2026-03-05

Phantom® Hindfoot TTC/TC Nail System

Applicant Paragon 28, Inc.

K number K253591

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HSB 2026-03-05

Arthrex FibuLock Nail System

Applicant Arthrex, Inc.

K number K252196

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HSB 2026-03-04

Active Intramedullary (AIM) Tibial Nail System

Applicant Satori Orthopaedics, Inc.

K number K252025

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HSB 2026-02-03

T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System

Applicant Stryker GmbH

K number K253640

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HSB 2025-12-12

Affixus® Natural Nail® Proximal Humeral System

Applicant Zimmer Switzerland Manufacturing GmbH

K number K253749

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HSB 2025-12-10

ARIX Femur Nail System

Applicant Jeil Medical Corporation

K number K252826

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HSB 2025-10-17

Estremo Fibular Nail

Applicant Citieffe S.R.L.

K number K250197

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HSB 2025-09-12

DynaNail TTC Fusion System

Applicant MedShape, Inc.

K number K250628

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HSB 2025-08-20

T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System

Applicant Stryker GmbH

K number K251400

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HSB 2025-08-13

T2 Alpha Femur Retrograde Nailing System

Applicant Stryker GmbH

K number K250163

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HSB 2025-08-07

Succession™ AFN System

Applicant Ortho Solutions UK , Ltd.

K number K250622

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HSB 2025-07-14

Phantom® Hindfoot TTC/TC Nail System

Applicant Paragon 28, Inc.

K number K251850

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HSB 2025-06-12

GMReis Fibula Nail System

Applicant Gm Dos Reis Industria E Comercio

K number K250559

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HSB 2025-04-22

ARIX Femur Nail System

Applicant Jeil Medical Corporation

K number K242247

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HSB 2025-04-10

FitboneTM Trochanteric

Applicant Orthofix Srl

K number K250112

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HSB 2025-04-01

Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur

Applicant OrthoPediatrics Corp.

K number K250623

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HSB 2025-02-21

Fassier-Duval Telescoping IM System

Applicant Orthopediatrics Canada Ulc Dba Pega Medical

K number K241983

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HSB 2025-02-12

Affixus Tibial Nailing System - 4mm screws

Applicant Zimmer, Inc.

K number K243907

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HSB 2025-01-13

Arthrex Intramedullary Nails

Applicant Arthrex, Inc.

K number K243890

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HSB 2024-12-09

TRIGEN META-TAN Trochanteric Antegrade Nail

Applicant Smith & Nephew, Inc.

K number K243364

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HSB 2024-11-05

Atlas™ Humeral Nail System

Applicant Orthopedic Designs North America, Inc. (Odi-Na)

K number K241484

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HSB 2024-09-26

Affixus Tibial and Antegrade Femoral Nailing System

Applicant Zimmer, Inc.

K number K241651

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HSB 2024-08-22

Phantom Fibula Nail System

Applicant Paragon 28, Inc.

K number K234128

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HSB 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

Applicant Tdm Co., Ltd.

K number K230071

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HSB 2024-08-01

DePuy Synthes Retrograde Femoral Nail Advanced System

Applicant DePuy Synthes

K number K233696

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HSB 2024-06-18

Fitbone Trochanteric

Applicant Orthofix Srl

K number K233867

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HSB 2024-05-03

RODEO Telescopic Nail

Applicant Orthofix Srl

K number K232648

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HSB 2024-04-04

Vertex Hip Fracture Nailing System

Applicant Orthoxel Dac

K number K233910

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HSB 2024-03-22

FITBONE® Transport and Lengthening System

Applicant Orthofix Srl

K number K232169

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HSB 2024-02-12

I.T.S. INS Proximal Femur Nail

Applicant I.T.S. GmbH

K number K233134

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HSB 2024-02-05

Flow-Nail

Applicant Flow-Fx, LLC

K number K234075

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HSB 2024-01-30

Redemption Duo Hindfoot Nail System

Applicant Vilex, LLC

K number K231343

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HSB 2023-12-15

Precice Max System

Applicant Nuvasive Specialized Orthopedics, Incorporated

K number K232267

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HSB 2023-10-31

Tornier Humeral Nail and Tornier Long Humeral Nail

Applicant Tornier, Inc.

K number K230352

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HSB 2023-08-29

Precice Ankle Salvage System

Applicant Nuvasive Specialized Orthopedics, Inc.

K number K230765

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HSB 2023-08-21

Pediatric Nailing Platform Tibia

Applicant OrthoPediatrics Corp.

K number K231266

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HSB 2023-08-09

Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System

Applicant Zimmer Switzerland Manufacturing GmbH

K number K231114

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HSB 2023-07-17

Arthrex Intramedullary Nails

Applicant Arthrex, Inc.

K number K230257

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HSB 2023-06-30

SGM Femoral Nail System

Applicant Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

K number K230456

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HSB 2023-06-09

Gamma4 System

Applicant Stryker GmbH

K number K230512

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HSB 2023-03-15

Precice Intramedullary Limb Lengthening System

Applicant Nuvasive Specialized Orthopedics, Inc.

K number K220234

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HSB 2023-03-06

Pro-X1™ Trochanteric Nailing System

Applicant X-Bolt Orthopedics

K number K221621

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HSB 2023-03-03

Dyna Locking Trochanteric Nail™

Applicant Innosys

K number K221084

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HSB 2022-12-21

Advanced Intramedullary Nail System

Applicant Double Medical Technology, Inc.

K number K221221

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HSB 2022-12-20

Arthrex DualCompression Hindfoot Fusion Nail Implant System

Applicant Arthrex, Inc.

K number K221031

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HSB 2022-12-06

Femoral Trochanteric Nail System – Neonail

Applicant Neoortho Produtos Ortopédicos S/A

K number K221021

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HSB 2022-11-21

Flex-Thread™ Ulna Intramedullary Nail System

Applicant Flower Orthopedics Corporation Dba Conventus Flower

K number K222390

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HSB 2022-11-15

Gamma4 System

Applicant Stryker GmbH

K number K222309

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HSB 2022-11-14

Smith & Nephew Intramedullary Nail Systems

Applicant Smith & Nephew, Inc.

K number K210980

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HSB 2022-10-27

Artemis Proximal Femoral Nail System

Applicant Glw, Inc.

K number K221489

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HSB 2022-09-09

AUTOBAHN(R) EVO Femoral Nails

Applicant Globus Medical, Inc.

K number K220659

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HSB 2022-07-20

Pediatric Nailing Platform Femur

Applicant OrthoPediatrics Corp.

K number K220679

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HSB 2022-05-13

Flow-Nail

Applicant Flow-Fx, LLC

K number K221115

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HSB 2022-02-11

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System

Applicant Stryker GmbH

K number K213328

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HSB 2022-02-10

GPC Intraheal Intramedullary Nailing System

Applicant Gpc Medical Limited

K number K203811

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HSB 2021-12-21

The Progen™ Trochanteric Nail System

Applicant Ortho Development Corporation

K number K211086

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HSB 2021-07-23

Flex-Thread™ Distal Fibula lntramedullary Nail System

Applicant Flower Orthopedics Corporation Dba Conventus Flower

K number K212030

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HSB 2021-07-19

Elos® Intramedullary Nailing System

Applicant Intrauma S.P.A

K number K201147

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HSB 2021-06-28

Phantom Hindfoot TTC/TC Nail System

Applicant Paragon 28, Inc.

K number K210869

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HSB 2021-05-26

Fassier-Duval Telescopic IM System

Applicant Pega Medical, Inc.

K number K211292

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HSB 2021-03-18

Adaptable Ortho Innovations Intramedullary Nail System

Applicant Adaptable Ortho Innovations, LLC

K number K210285

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HSB 2021-02-26

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

Applicant Stryker GmbH

K number K203819

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HSB 2021-02-19

Artemis Proximal Femoral Nail System

Applicant Glw, Inc.

K number K201379

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HSB 2021-02-17

FITBONE(R) TAA

Applicant Wittenstein Intens GmbH

K number K203399

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HSB 2021-01-22

Flex-ThreadTM Distal Fibula Intramedullary Nail System

Applicant Conventus Orthopaedics, LLC

K number K202858

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HSB 2020-12-22

External Remote Controller ERC 4P

Applicant Nuvasive Specialized Orthopedics, Inc.

K number K202348

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HSB 2020-10-28

Syntec Femoral Nail Extended System

Applicant Syntec Scientific Corporation

K number K202935

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HSB 2020-10-01

TELEGRAPH® EVOLUTION Humeral Nailing System

Applicant FH Industrie

K number K200127

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HSB 2020-09-23

DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm

Applicant Synthes (USA) Products, LLC

K number K201346

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HSB 2020-09-16

Precice® Ankle Salvage System

Applicant Nuvasive Specialized Orthopedics, Inc.

K number K200430

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HSB 2020-08-28

AOS Galileo™ Trochanteric Nail System

Applicant Advanced Orthopaedic Solutions, Inc.

K number K202099

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HSB 2020-08-27

ANSER Clavicle Pin

Applicant BAAT Medical Products B.V.

K number K201830

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HSB 2020-08-10

Precice® Bone Transport System

Applicant Nuvasive Specialized Orthopedics, Inc.

K number K201567

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HSB 2020-07-22

Gamma3 System

Applicant Stryker Trauma GmbH

K number K200869

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HSB 2020-07-17

Phantom® Hindfoot TTC/TC Nail System

Applicant Paragon 28, Inc.

K number K201227

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HSB 2020-07-01

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

Applicant Stryker GmbH

K number K200880

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HSB 2020-06-24

The Simple Locking Intramedullary (Slim) System

Applicant Pega Medical, Inc.

K number K192710

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HSB 2020-05-08

Precice® Screws

Applicant Nuvasive Specialized Orthopedics, Inc.

K number K193617

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HSB 2020-05-08

PRECICE Bone Transport System

Applicant Nuvasive Specialized Orthopedics, Inc.

K number K193016

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HSB 2020-04-28

Affixus(R) Natural Nail(R) System Humeral Nail

Applicant Zimmer GmbH

K number K200814

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HSB 2020-02-23

T2 Alpha Tibia Nailing System, IMN Screws System

Applicant Stryker Trauma GmbH

K number K193308

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HSB 2020-01-31

TTC Phantom® Intramedullary Nail System

Applicant Paragon 28, Inc.

K number K192163

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HSB 2019-11-14

EBA One Nailing System

Applicant Citieffe S.R.L.

K number K183666

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HSB 2019-10-11

Zimmer Natural Nail System Cephalomedullary Nails

Applicant Zimmer GmbH

K number K192312

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HSB 2019-10-09

Pediatric Nailing PlatformFemur

Applicant OrthoPediatrics Corp.

K number K190321

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HSB 2019-09-26

PRECICE System

Applicant Nuvasive Specialized Orthopedics, Inc.

K number K191336

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HSB 2019-09-06

TTC Phantom Intramedullary Nail System

Applicant Paragon 28, Inc.

K number K191782

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