FDA product code HSN: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
HSN is the FDA product code for prosthesis, ankle, semi-constrained, cemented, metal/polymer. It is a Class II device, regulated under 21 CFR 888.3110 and reviewed by the Orthopedic panel. FDA has cleared 68 510(k) submissions under HSN, 18 in the last five years, from 22 different applicants. The average 510(k) review took 131 days (median 114); 164 days on average over the last three years. FDA has posted 47 recalls for HSN devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class II |
| Regulation | 21 CFR 888.3110 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for HSN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 162 |
| 2018 | 4 | 118 |
| 2019 | 2 | 104 |
| 2020 | 6 | 185 |
| 2021 | 4 | 105 |
| 2022 | 1 | 30 |
| 2023 | 6 | 118 |
| 2024 | 7 | 144 |
| 2025 | 3 | 84 |
| 2026 | 1 | 263 |
Compare with all 510(k) review times · Search every HSN clearance
Top HSN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wrightmedicaltechnologyinc | 21 | 2023-01-27 |
| Paragon 28, Inc. | 7 | 2025-05-01 |
| Restor3D | 4 | 2025-09-03 |
| In2bones Sas | 4 | 2024-04-23 |
| Exactech, Inc. | 4 | 2023-10-12 |
17 more applicants have HSN clearances. See the full list in Caduvo.
Most recent HSN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253159 | Wright Medical Technology, Inc. (Stryker) | Prophecy Incompass Surgical Planning System | 2026-06-16 | 263 |
| K252454 | Restor3D | Kinos Total Ankle System | 2025-09-03 | 30 |
| K250037 | Wright Medical Technology, Inc. (Stryker) | Incompass Total Ankle System | 2025-06-20 | 163 |
| K250641 | Paragon 28, Inc. | APEX 3D Total Ankle Replacement System | 2025-05-01 | 58 |
| K240475 | Vilex, LLC | Hintermann Series H2 Total Ankle System | 2024-12-02 | 286 |
Recalls for HSN devices
47 product recalls in 17 recall events; 8 initiated in the last five years and 8 still open. Most recent: 2024-03-06.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2019 | 27 |
| 2020 | 2 |
| 2021 | 3 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code HSN?
HSN is the FDA product code for prosthesis, ankle, semi-constrained, cemented, metal/polymer. It is a Class II device, regulated under 21 CFR 888.3110 and reviewed by the Orthopedic panel.
What device class is HSN?
Class II, regulation 21 CFR 888.3110. Typical premarket route: 510(k).
How long does a 510(k) take for product code HSN?
Across 68 cleared submissions the average was 131 days from receipt to decision (median 114).
Which companies have the most HSN clearances?
Wrightmedicaltechnologyinc (21); Paragon 28, Inc. (7); Restor3D (4); In2bones Sas (4); Exactech, Inc. (4).
Have HSN devices been recalled?
Yes: 47 product recalls across 17 recall events; the most recent began 2024-03-06.
Next steps
- Run an FDA pathway report with predicate devices for product code HSN
- Run a recall and safety report across every HSN manufacturer
- Watch product code HSN 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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