FDA product code HSB: Rod, Fixation, Intramedullary And Accessories
HSB is the FDA product code for rod, fixation, intramedullary and accessories. It is a Class II device, regulated under 21 CFR 888.3020 and reviewed by the Orthopedic panel. FDA has cleared 530 510(k) submissions under HSB, 67 in the last five years, from 180 different applicants. The average 510(k) review took 118 days (median 86); 162 days on average over the last three years. FDA has posted 690 recalls for HSB devices, 40 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class II |
| Regulation | 21 CFR 888.3020 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for HSB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 23 | 146 |
| 2018 | 17 | 146 |
| 2019 | 13 | 144 |
| 2020 | 17 | 121 |
| 2021 | 10 | 143 |
| 2022 | 12 | 215 |
| 2023 | 11 | 200 |
| 2024 | 13 | 203 |
| 2025 | 15 | 124 |
| 2026 | 16 | 158 |
Compare with all 510(k) review times · Search every HSB clearance
Top HSB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Howmedica Osteonics Corp. | 38 | 2012-02-15 |
| Howmedica Corp. | 23 | 1998-11-20 |
| Synthes (Usa) | 22 | 2014-03-31 |
| Zimmer, Inc. | 17 | 2026-03-12 |
| Nuvasive Specialized Orthopedics, Inc. | 16 | 2023-08-29 |
175 more applicants have HSB clearances. See the full list in Caduvo.
Most recent HSB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261481 | Stryker GmbH | Pangea Femur Reconstruction System | 2026-06-29 | 55 |
| K261651 | NuVasive Specialized Orthopedics | Precice Max System and Precice Ankle Salvage System | 2026-06-18 | 30 |
| K253080 | Suzhou and Science & Technology Development Corp. | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) | 2026-06-18 | 268 |
| K253155 | Beijing Fule Science & Technology Development Co., Ltd. | Fule Metallic Lockable Intramedullary Nail Systems | 2026-06-17 | 264 |
| K253046 | ZheJiang Decans Medical Devices Co., Ltd. | HERA Interlocking Intramedullary Nailing System | 2026-06-16 | 267 |
Recalls for HSB devices
690 product recalls in 116 recall events; 40 initiated in the last five years and 48 still open. Most recent: 2026-03-16.
| Year | Recalls |
|---|---|
| 2017 | 102 |
| 2018 | 212 |
| 2019 | 7 |
| 2020 | 21 |
| 2021 | 12 |
| 2022 | 1 |
| 2023 | 9 |
| 2024 | 5 |
| 2025 | 22 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code HSB?
HSB is the FDA product code for rod, fixation, intramedullary and accessories. It is a Class II device, regulated under 21 CFR 888.3020 and reviewed by the Orthopedic panel.
What device class is HSB?
Class II, regulation 21 CFR 888.3020. Typical premarket route: 510(k).
How long does a 510(k) take for product code HSB?
Across 530 cleared submissions the average was 118 days from receipt to decision (median 86).
Which companies have the most HSB clearances?
Howmedica Osteonics Corp. (38); Howmedica Corp. (23); Synthes (Usa) (22); Zimmer, Inc. (17); Nuvasive Specialized Orthopedics, Inc. (16).
Have HSB devices been recalled?
Yes: 690 product recalls across 116 recall events; the most recent began 2026-03-16.
Next steps
- Run an FDA pathway report with predicate devices for product code HSB
- Run a recall and safety report across every HSB manufacturer
- Watch product code HSB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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