Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HSB — Predicate Candidate Screening
530 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
258 days90th percentile
530clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261481 | Pangea Femur Reconstruction System | Stryker GmbH | 2026-06-29 | 55 | 0 |
| K261651 | Precice™ Max System and Precice™ Ankle Salvage System | NuVasive Specialized Orthopedics | 2026-06-18 | 30 | 0 |
| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femora | Suzhou and Science & Technology Development Corp. | 2026-06-18 | 268 | 0 |
| K253155 | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | 2026-06-17 | 264 | 0 |
| K253046 | HERA Interlocking Intramedullary Nailing System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-06-16 | 267 | 0 |
| K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | Orthofix Srl | 2026-05-19 | 119 | 0 |
| K253991 | Fitbone™ Trochanteric, FITBONE® Transport and Lengthening Sy | Orthofix Srl | 2026-05-08 | 147 | 0 |
| K261043 | AUTOBAHN™ Nailing System | Globus Medical, Inc. | 2026-04-24 | 24 | 0 |
| K252016 | Arthrex Humeral Nails | Arthrex, Inc. | 2026-03-20 | 266 | 0 |
| K252961 | Fusion FibFix Nail | Fusion Orthopedics USA, LLC | 2026-03-18 | 183 | 0 |
| K253566 | Affixus Retrograde Femoral Nailing System | Zimmer, Inc. | 2026-03-12 | 115 | 0 |
| K253517 | Reselute Tibial Nail | Reselute, Inc. | 2026-03-10 | 118 | 0 |
| K253591 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2026-03-05 | 108 | 0 |
| K252196 | Arthrex FibuLock Nail System | Arthrex, Inc. | 2026-03-05 | 234 | 0 |
| K252025 | Active Intramedullary (AIM) Tibial Nail System | Satori Orthopaedics, Inc. | 2026-03-04 | 247 | 0 |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Recon | Stryker GmbH | 2026-02-03 | 76 | 0 |
| K253749 | Affixus® Natural Nail® Proximal Humeral System | Zimmer Switzerland Manufacturing GmbH | 2025-12-12 | 17 | 0 |
| K252826 | ARIX Femur Nail System | Jeil Medical Corporation | 2025-12-10 | 96 | 0 |
| K250197 | Estremo Fibular Nail | Citieffe S.R.L. | 2025-10-17 | 267 | 0 |
| K250628 | DynaNail TTC Fusion System | MedShape, Inc. | 2025-09-12 | 193 | 0 |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Naili | Stryker GmbH | 2025-08-20 | 106 | 0 |
| K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | 2025-08-13 | 204 | 0 |
| K250622 | Succession™ AFN System | Ortho Solutions UK , Ltd. | 2025-08-07 | 160 | 0 |
| K251850 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2025-07-14 | 28 | 0 |
| K250559 | GMReis Fibula Nail System | Gm Dos Reis Industria E Comercio | 2025-06-12 | 107 | 0 |
| K242247 | ARIX Femur Nail System | Jeil Medical Corporation | 2025-04-22 | 265 | 0 |
| K250112 | FitboneTM Trochanteric | Orthofix Srl | 2025-04-10 | 84 | 0 |
| K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform | OrthoPediatrics Corp. | 2025-04-01 | 29 | 0 |
| K241983 | Fassier-Duval Telescoping IM System | Orthopediatrics Canada Ulc Dba Pega Medical | 2025-02-21 | 228 | 0 |
| K243907 | Affixus Tibial Nailing System - 4mm screws | Zimmer, Inc. | 2025-02-12 | 55 | 0 |
| K243890 | Arthrex Intramedullary Nails | Arthrex, Inc. | 2025-01-13 | 26 | 0 |
| K243364 | TRIGEN META-TAN Trochanteric Antegrade Nail | Smith & Nephew, Inc. | 2024-12-09 | 41 | 0 |
| K241484 | Atlas™ Humeral Nail System | Orthopedic Designs North America, Inc. (Odi-Na) | 2024-11-05 | 165 | 0 |
| K241651 | Affixus Tibial and Antegrade Femoral Nailing System | Zimmer, Inc. | 2024-09-26 | 111 | 17 |
| K234128 | Phantom Fibula Nail System | Paragon 28, Inc. | 2024-08-22 | 238 | 1 |
| K230071 | Femur Reconstruction Interlocking Nail System, Femur Retrogr | Tdm Co., Ltd. | 2024-08-22 | 590 | 0 |
| K233696 | DePuy Synthes Retrograde Femoral Nail Advanced System | DePuy Synthes | 2024-08-01 | 258 | 0 |
| K233867 | Fitbone Trochanteric | Orthofix Srl | 2024-06-18 | 195 | 1 |
| K232648 | RODEO Telescopic Nail | Orthofix Srl | 2024-05-03 | 246 | 0 |
| K233910 | Vertex Hip Fracture Nailing System | Orthoxel Dac | 2024-04-04 | 114 | 0 |
| K232169 | FITBONE® Transport and Lengthening System | Orthofix Srl | 2024-03-22 | 245 | 0 |
| K233134 | I.T.S. INS Proximal Femur Nail | I.T.S. GmbH | 2024-02-12 | 138 | 0 |
| K234075 | Flow-Nail | Flow-Fx, LLC | 2024-02-05 | 26 | 0 |
| K231343 | Redemption Duo Hindfoot Nail System | Vilex, LLC | 2024-01-30 | 266 | 0 |
| K232267 | Precice Max System | Nuvasive Specialized Orthopedics, Incorporated | 2023-12-15 | 137 | 1 |
| K230352 | Tornier Humeral Nail and Tornier Long Humeral Nail | Tornier, Inc. | 2023-10-31 | 264 | 0 |
| K230765 | Precice Ankle Salvage System | Nuvasive Specialized Orthopedics, Inc. | 2023-08-29 | 162 | 0 |
| K231266 | Pediatric Nailing Platform Tibia | OrthoPediatrics Corp. | 2023-08-21 | 111 | 0 |
| K231114 | Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus | Zimmer Switzerland Manufacturing GmbH | 2023-08-09 | 112 | 0 |
| K230257 | Arthrex Intramedullary Nails | Arthrex, Inc. | 2023-07-17 | 167 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda