FDA product code · Orthopedic
Trephine
FDA lists HWK as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 888.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1985. No recall names this code.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of HWK at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · HWK
FDA has decided no HWK device since 2007.
Median 510(k) review, days · HWK
Too few HWK 510(k)s in any year since 2007 to give a median.
Recalls per year · HWK
No recall names HWK since 2007.
Adverse event reports per year · HWK
5in 2025
MAUDE reports naming product code HWK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 13 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
Planning a device in HWK? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 888.4540.