FDA product code HWX: Tap, Bone
HWX is the FDA product code for tap, bone. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under HWX, from 2 different applicants. The average 510(k) review took 56 days (median 56). FDA has posted 15 recalls for HWX devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tap, Bone |
| 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 HWX clearance
Top HWX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Buckman Co., Inc. | 1 | 1987-09-02 |
| Amtech Scientific, Inc. | 1 | 1984-05-14 |
Most recent HWX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K873067 | Buckman Co., Inc. | ACROMED BONE SCREW TAP SLEEVES | 1987-09-02 | 28 |
| K840735 | Amtech Scientific, Inc. | FEMORAL CEMENT REMOVAL INSTRUMENT | 1984-05-14 | 83 |
Recalls for HWX devices
15 product recalls in 8 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-02-25.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code HWX?
HWX is the FDA product code for tap, bone. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HWX?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HWX?
Across 2 cleared submissions the average was 56 days from receipt to decision (median 56).
Which companies have the most HWX clearances?
Buckman Co., Inc. (1); Amtech Scientific, Inc. (1).
Have HWX devices been recalled?
Yes: 15 product recalls across 8 recall events; the most recent began 2026-02-25.
Next steps
- Run an FDA pathway report with predicate devices for product code HWX
- Run a recall and safety report across every HWX manufacturer
- Watch product code HWX 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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