Product code HSB: 510(k) clearances and predicates
Product code HSB covers Pediatric Nailing Platform Femur. FDA lists 531 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
531 clearances on file under product code HSB. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 12 |
| 2023 | 11 |
| 2024 | 13 |
| 2025 | 15 |
| 2026 so far | 17 |
Recent clearances
Newest HSB clearances in the FDA index, with applicant and decision date:
- K261345, Pediatric Nailing Platform Femur, applicant OrthoPediatrics Corp., decided 2026-09-24. FDA record
- K261481, Pangea Femur Reconstruction System, applicant Stryker GmbH, decided 2026-06-29. FDA record
- K253080, AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02), applicant Suzhou and Science & Technology Development Corp., decided 2026-06-18. FDA record
- K261651, Precice Max System and Precice Ankle Salvage System, applicant NuVasive Specialized Orthopedics, decided 2026-06-18. FDA record
- K253155, Fule Metallic Lockable Intramedullary Nail Systems, applicant Beijing Fule Science & Technology Development Co., Ltd., decided 2026-06-17. FDA record
- K253046, HERA Interlocking Intramedullary Nailing System, applicant ZheJiang Decans Medical Devices Co., Ltd., decided 2026-06-16. FDA record
- K260146, FITBONE® TRANSPORT AND LENGTHENING SYSTEM, applicant Orthofix Srl, decided 2026-05-19. FDA record
- K253991, Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA, applicant Orthofix Srl, decided 2026-05-08. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Pangea Femur Reconstruction System, AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02). Watch new HSB clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code HSB?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent HSB clearances include Pediatric Nailing Platform Femur.
How many 510(k) clearances use product code HSB?
531 at the time this page was generated, from openFDA records.
How do I find a predicate device under HSB?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new HSB clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.