FDA product code HTW: Bit, Drill
HTW is the FDA product code for bit, drill. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 11 510(k) submissions under HTW, from 11 different applicants. The average 510(k) review took 94 days (median 41). FDA has posted 114 recalls for HTW devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bit, Drill |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HTW clearance
Top HTW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Renovo Life, LLC | 1 | 2016-01-15 |
| Hand Biomechanics Lab, Inc. | 1 | 1994-12-22 |
| Neoligaments, Ltd. | 1 | 1993-08-06 |
| W. L. Gore & Associates, Inc. | 1 | 1992-01-16 |
| Mitek Surgical Products, Inc. | 1 | 1989-10-06 |
6 more applicants have HTW clearances. See the full list in Caduvo.
Most recent HTW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K151661 | Renovo Life, LLC | Renovo Life Hard Carbon Coated Drill Bit | 2016-01-15 | 210 |
| K942906 | Hand Biomechanics Lab, Inc. | AGEE-WRISTJACK PRE-DRILL KIT | 1994-12-22 | 184 |
| K930339 | Neoligaments, Ltd. | REAMER BIT | 1993-08-06 | 193 |
| K915692 | W. L. Gore & Associates, Inc. | CANNULATED DRILL BIT | 1992-01-16 | 24 |
| K892903 | Mitek Surgical Products, Inc. | MITEK ANCHOR DRILL | 1989-10-06 | 169 |
Recalls for HTW devices
114 product recalls in 34 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-02-11.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 62 |
| 2020 | 2 |
| 2021 | 6 |
| 2024 | 2 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code HTW?
HTW is the FDA product code for bit, drill. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HTW?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HTW?
Across 11 cleared submissions the average was 94 days from receipt to decision (median 41).
Which companies have the most HTW clearances?
Renovo Life, LLC (1); Hand Biomechanics Lab, Inc. (1); Neoligaments, Ltd. (1); W. L. Gore & Associates, Inc. (1); Mitek Surgical Products, Inc. (1).
Have HTW devices been recalled?
Yes: 114 product recalls across 34 recall events; the most recent began 2026-02-11.
Next steps
- Run an FDA pathway report with predicate devices for product code HTW
- Run a recall and safety report across every HTW manufacturer
- Watch product code HTW 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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