ClearanceBrief
Panels › Orthopedic › Product code HSB · Class 2

Rod, Fixation, Intramedullary And Accessories

Regulation 888.3020

20510(k)s in 12 months (532 all time)
19recalls in 12 months (690 all time)
680recalls that name a 510(k)
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Top companies in HSB

Company510(k)sRecalls
Zimmer Biomet, Inc.0295
DePuy Orthopaedics, Inc.9116
Zimmer GmbH2350
Stryker1237
Howmedica Osteonics390
OrthoPediatrics Corp.731
Ebi, L.P.131
Advanced Orthopaedic Solutions, Inc.1512
NuVasive Specialized Orthopedics189
Synthes (Usa)234
Decided510(k)Device and applicantCode
Oct 19, 2026K261189Freedom Nail Ankle Fusion System
McGinley Orthopaedic Innovations
HSB
Sep 24, 2026K261345Pediatric Nailing Platform Femur
OrthoPediatrics Corp.
HSB
Jun 29, 2026K261481Pangea Femur Reconstruction System
Stryker GmbH, CH
HSB
Jun 18, 2026K261651Precice™ Max System and Precice™ Ankle Salvage System
NuVasive Specialized Orthopedics
HSB
Jun 18, 2026K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
Suzhou and Science & Technology Development Corp., CN
HSB
Jun 17, 2026K253155Fule Metallic Lockable Intramedullary Nail Systems
Beijing Fule Science & Technology Development Co., Ltd., CN
HSB
Jun 16, 2026K253046HERA Interlocking Intramedullary Nailing System
ZheJiang Decans Medical Devices Co., Ltd., CN
HSB
May 19, 2026K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEM
Orthofix Srl, IT
HSB
May 8, 2026K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
Orthofix Srl, IT
HSB
Apr 24, 2026K261043AUTOBAHN™ Nailing System
Globus Medical, Inc.
HSB
Mar 20, 2026K252016Arthrex Humeral Nails
Arthrex, Inc.
HSB
Mar 18, 2026K252961Fusion FibFix Nail
Fusion Orthopedics USA, LLC
HSB
Mar 12, 2026K253566Affixus Retrograde Femoral Nailing System
Zimmer, Inc.
HSB
Mar 10, 2026K253517Reselute Tibial Nail
Reselute, Inc.
HSB
Mar 5, 2026K253591Phantom® Hindfoot TTC/TC Nail System
Paragon 28, Inc.
HSB
Mar 5, 2026K252196Arthrex FibuLock Nail System
Arthrex, Inc.
HSB
Mar 4, 2026K252025Active Intramedullary (AIM) Tibial Nail System
Satori Orthopaedics, Inc.
HSB
Feb 3, 2026K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System
Stryker GmbH, CH
HSB
Dec 12, 2025K253749Affixus® Natural Nail® Proximal Humeral System
Zimmer Switzerland Manufacturing GmbH, CH
HSB
Dec 10, 2025K252826ARIX Femur Nail System
Jeil Medical Corporation, KR
HSB
Oct 17, 2025K250197Estremo Fibular Nail
Citieffe S.R.L., IT
HSB
Sep 12, 2025K250628DynaNail TTC Fusion System
MedShape, Inc.
HSB
Aug 20, 2025K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System
Stryker GmbH, CH
HSB
Aug 13, 2025K250163T2 Alpha Femur Retrograde Nailing System
Stryker GmbH, CH
HSB
Aug 7, 2025K250622Succession™ AFN System
Ortho Solutions UK , Ltd., GB
HSB
Jul 14, 2025K251850Phantom® Hindfoot TTC/TC Nail System
Paragon 28, Inc.
HSB
Jun 12, 2025K250559GMReis Fibula Nail System
Gm Dos Reis Industria E Comercio, BR
HSB
Apr 22, 2025K242247ARIX Femur Nail System
Jeil Medical Corporation, KR
HSB
Apr 10, 2025K250112FitboneTM Trochanteric
Orthofix Srl, IT
HSB
Apr 1, 2025K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur
OrthoPediatrics Corp.
HSB
Feb 21, 2025K241983Fassier-Duval Telescoping IM System
Orthopediatrics Canada Ulc Dba Pega Medical, CA
HSB
Feb 12, 2025K243907Affixus Tibial Nailing System - 4mm screws
Zimmer, Inc.
HSB
Jan 13, 2025K243890Arthrex Intramedullary Nails
Arthrex, Inc.
HSB
Dec 9, 2024K243364TRIGEN META-TAN Trochanteric Antegrade Nail
Smith & Nephew, Inc.
HSB
Nov 5, 2024K241484Atlas™ Humeral Nail System
Orthopedic Designs North America, Inc. (Odi-Na)
HSB
Sep 26, 2024K241651Affixus Tibial and Antegrade Femoral Nailing System
Zimmer, Inc.
HSB
Aug 22, 2024K234128Phantom Fibula Nail System
Paragon 28, Inc.
HSB
Aug 22, 2024K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail Syst
Tdm Co., Ltd., KR
HSB
Aug 1, 2024K233696DePuy Synthes Retrograde Femoral Nail Advanced System
DePuy Synthes
HSB
Jun 18, 2024K233867Fitbone Trochanteric
Orthofix Srl, IT
HSB
May 3, 2024K232648RODEO Telescopic Nail
Orthofix Srl, IT
HSB
Apr 4, 2024K233910Vertex Hip Fracture Nailing System
Orthoxel Dac, IE
HSB
Mar 22, 2024K232169FITBONE® Transport and Lengthening System
Orthofix Srl, IT
HSB
Feb 12, 2024K233134I.T.S. INS Proximal Femur Nail
I.T.S. GmbH, AT
HSB
Feb 5, 2024K234075Flow-Nail
Flow-Fx, LLC
HSB
Jan 30, 2024K231343Redemption Duo Hindfoot Nail System
Vilex, LLC
HSB
Dec 15, 2023K232267Precice Max System
Nuvasive Specialized Orthopedics, Incorporated
HSB
Oct 31, 2023K230352Tornier Humeral Nail and Tornier Long Humeral Nail
Tornier, Inc.
HSB
Aug 29, 2023K230765Precice Ankle Salvage System
Nuvasive Specialized Orthopedics, Inc.
HSB
Aug 21, 2023K231266Pediatric Nailing Platform Tibia
OrthoPediatrics Corp.
HSB

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