FDA product code HTN: Washer, Bolt Nut
HTN is the FDA product code for washer, bolt nut. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 93 510(k) submissions under HTN, 19 in the last five years, from 51 different applicants. The average 510(k) review took 112 days (median 90); 151 days on average over the last three years. FDA has posted 4 recalls for HTN devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Washer, Bolt Nut |
| Device class | Class II |
| Regulation | 21 CFR 888.3030 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for HTN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 6 | 108 |
| 2018 | 2 | 165 |
| 2019 | 5 | 158 |
| 2020 | 3 | 134 |
| 2021 | 2 | 114 |
| 2022 | 5 | 82 |
| 2023 | 2 | 63 |
| 2024 | 6 | 105 |
| 2025 | 4 | 83 |
| 2026 | 2 | 264 |
Compare with all 510(k) review times · Search every HTN clearance
Top HTN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arthrex, Inc. | 16 | 2025-12-22 |
| Dallen Medical, Inc. | 5 | 2015-05-07 |
| Synthes (Usa) | 5 | 2002-02-08 |
| Acumed, LLC | 4 | 2025-01-23 |
| Acu Med, Inc. | 4 | 1997-03-17 |
46 more applicants have HTN clearances. See the full list in Caduvo.
Most recent HTN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253115 | Movmedix S.A.S. | LARS ACJ | 2026-06-10 | 259 |
| K252081 | Lincotek Medical | SportLinc Syndesmosis Device | 2026-03-27 | 268 |
| K253727 | Arthrex, Inc. | Syndesmosis TightRope PRO | 2025-12-22 | 28 |
| K251643 | Wright Medical Technology, Inc. (Stryker Corporation) | Synchfix EVT | 2025-10-29 | 153 |
| K251134 | TriMed, Inc. | RipCord | 2025-07-11 | 91 |
Recalls for HTN devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-12-22.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code HTN?
HTN is the FDA product code for washer, bolt nut. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is HTN?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code HTN?
Across 93 cleared submissions the average was 112 days from receipt to decision (median 90).
Which companies have the most HTN clearances?
Arthrex, Inc. (16); Dallen Medical, Inc. (5); Synthes (Usa) (5); Acumed, LLC (4); Acu Med, Inc. (4).
Have HTN devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2022-12-22.
Next steps
- Run an FDA pathway report with predicate devices for product code HTN
- Run a recall and safety report across every HTN manufacturer
- Watch product code HTN 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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