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HSB

Rod, Fixation, Intramedullary And Accessories

Product code
HSB
Device name
Rod, Fixation, Intramedullary And Accessories
Device class
Class 2
21 CFR
21 CFR 888.3020
Medical specialty
Orthopedic
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
530

510(k) clearances, last 3 years (46)

Last three years. Most recent: 2026-06-29.

NumberDecision dateApplicantDevice name
K2614812026-06-29Stryker GmbHPangea Femur Reconstruction System summary
K2530802026-06-18Suzhou and Science & Technology DeveloAND Medical Femoral Nail System (PFNA01); AND Medica summary
K2616512026-06-18NuVasive Specialized OrthopedicsPrecice™ Max System and Precice™ Ankle Salvage Syste summary
K2531552026-06-17Beijing Fule Science & Technology DeveFule Metallic Lockable Intramedullary Nail Systems summary
K2530462026-06-16ZheJiang Decans Medical Devices Co., LHERA Interlocking Intramedullary Nailing System summary
K2601462026-05-19Orthofix SrlFITBONE® TRANSPORT AND LENGTHENING SYSTEM summary
K2539912026-05-08Orthofix SrlFitbone™ Trochanteric, FITBONE® Transport and Lengt summary
K2610432026-04-24Globus Medical, Inc.AUTOBAHN™ Nailing System summary
K2520162026-03-20Arthrex, Inc.Arthrex Humeral Nails summary
K2529612026-03-18Fusion Orthopedics USA, LLCFusion FibFix Nail summary
K2535662026-03-12Zimmer, Inc.Affixus Retrograde Femoral Nailing System summary
K2535172026-03-10Reselute, Inc.Reselute Tibial Nail summary
K2521962026-03-05Arthrex, Inc.Arthrex FibuLock Nail System summary
K2535912026-03-05Paragon 28, Inc.Phantom® Hindfoot TTC/TC Nail System summary
K2520252026-03-04Satori Orthopaedics, Inc.Active Intramedullary (AIM) Tibial Nail System summary
K2536402026-02-03Stryker GmbHT2 Alpha Femur Retrograde Nailing System; Pangea Fem summary
K2537492025-12-12Zimmer Switzerland Manufacturing GmbHAffixus® Natural Nail® Proximal Humeral System summary
K2528262025-12-10Jeil Medical CorporationARIX Femur Nail System summary
K2501972025-10-17Citieffe S.R.L.Estremo Fibular Nail summary
K2506282025-09-12MedShape, Inc.DynaNail TTC Fusion System summary
K2514002025-08-20Stryker GmbHT2 Alpha Humerus Nailing System; IMN Screws System; summary
K2501632025-08-13Stryker GmbHT2 Alpha Femur Retrograde Nailing System summary
K2506222025-08-07Ortho Solutions UK , Ltd.Succession™ AFN System summary
K2518502025-07-14Paragon 28, Inc.Phantom® Hindfoot TTC/TC Nail System summary
K2505592025-06-12Gm Dos Reis Industria E ComercioGMReis Fibula Nail System summary
K2422472025-04-22Jeil Medical CorporationARIX Femur Nail System summary
K2501122025-04-10Orthofix SrlFitboneTM Trochanteric summary
K2506232025-04-01OrthoPediatrics Corp.Pediatric Nailing Platform Tibia Pediatric Nailing summary
K2419832025-02-21Orthopediatrics Canada Ulc Dba Pega MeFassier-Duval Telescoping IM System summary
K2439072025-02-12Zimmer, Inc.Affixus Tibial Nailing System - 4mm screws summary
K2438902025-01-13Arthrex, Inc.Arthrex Intramedullary Nails summary
K2433642024-12-09Smith & Nephew, Inc.TRIGEN META-TAN Trochanteric Antegrade Nail summary
K2414842024-11-05Orthopedic Designs North America, Inc.Atlas™ Humeral Nail System summary
K2416512024-09-26Zimmer, Inc.Affixus Tibial and Antegrade Femoral Nailing System summary
K2300712024-08-22Tdm Co., Ltd.Femur Reconstruction Interlocking Nail System, Femur summary
K2341282024-08-22Paragon 28, Inc.Phantom Fibula Nail System summary
K2336962024-08-01DePuy SynthesDePuy Synthes Retrograde Femoral Nail Advanced Syste summary
K2338672024-06-18Orthofix SrlFitbone Trochanteric summary
K2326482024-05-03Orthofix SrlRODEO Telescopic Nail summary
K2339102024-04-04Orthoxel DacVertex Hip Fracture Nailing System summary
K2321692024-03-22Orthofix SrlFITBONE® Transport and Lengthening System summary
K2331342024-02-12I.T.S. GmbHI.T.S. INS Proximal Femur Nail summary
K2340752024-02-05Flow-Fx, LLCFlow-Nail summary
K2313432024-01-30Vilex, LLCRedemption Duo Hindfoot Nail System summary
K2322672023-12-15Nuvasive Specialized Orthopedics, IncoPrecice Max System summary
K2303522023-10-31Tornier, Inc.Tornier Humeral Nail and Tornier Long Humeral Nail summary
Official FDA classification page: HSB
Classification and pathway per current FDA publications. Data from openFDA (CC0).