FDA product code HBW: Fastener, Plate, Cranioplasty
HBW is the FDA product code for fastener, plate, cranioplasty. It is a Class II device, regulated under 21 CFR 882.5360 and reviewed by the Neurology panel. FDA has cleared 7 510(k) submissions under HBW, 2 in the last five years, from 6 different applicants. The average 510(k) review took 143 days (median 109); 59 days on average over the last three years. FDA has posted 1 recall for HBW devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Fastener, Plate, Cranioplasty |
| Device class | Class II |
| Regulation | 21 CFR 882.5360 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for HBW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 29 |
| 2023 | 1 | 109 |
| 2025 | 1 | 59 |
Compare with all 510(k) review times · Search every HBW clearance
Top HBW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stryker | 2 | 2017-05-19 |
| Inion OY | 1 | 2025-07-11 |
| Stryker Leibinger GmbH & Co KG | 1 | 2023-08-14 |
| Depuy Synthes Companies of Johnson & Johnson | 1 | 2015-03-27 |
| Porex Surgical, Inc. | 1 | 2010-12-03 |
1 more applicants have HBW clearances. See the full list in Caduvo.
Most recent HBW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251472 | Inion OY | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System | 2025-07-11 | 59 |
| K231208 | Stryker Leibinger GmbH & Co KG | Stryker Resorbable Fixation System | 2023-08-14 | 109 |
| K171152 | Stryker | Stryker Universal Neuro III System AXS Screw | 2017-05-19 | 29 |
| K151387 | Stryker | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade | 2015-06-24 | 29 |
| K141385 | Depuy Synthes Companies of Johnson & Johnson | DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) | 2015-03-27 | 304 |
Recalls for HBW devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-01-24.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code HBW?
HBW is the FDA product code for fastener, plate, cranioplasty. It is a Class II device, regulated under 21 CFR 882.5360 and reviewed by the Neurology panel.
What device class is HBW?
Class II, regulation 21 CFR 882.5360. Typical premarket route: 510(k).
How long does a 510(k) take for product code HBW?
Across 7 cleared submissions the average was 143 days from receipt to decision (median 109).
Which companies have the most HBW clearances?
Stryker (2); Inion OY (1); Stryker Leibinger GmbH & Co KG (1); Depuy Synthes Companies of Johnson & Johnson (1); Porex Surgical, Inc. (1).
Have HBW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-01-24.
Next steps
- Run an FDA pathway report with predicate devices for product code HBW
- Run a recall and safety report across every HBW manufacturer
- Watch product code HBW 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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