510(k) · Cleared
ClearedSurgical Burs and Surgical Drill Bits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synvasive Technology, Inc. · HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Cleared on Aug 26, 1997 after a 54-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 26, 1997
- Review
- 54 days
- Class
- Class I
- Product code
- HWE
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HWE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | DePuy standard surgical burs and surgical drill bits Named without a submission number | |
| * | — | MicroAire standard surgical burs and surgical drill bits Named without a submission number | |
| * | — | Synthes standard surgical burs and surgical drill bits Named without a submission number | |
| * | — | Zimmer standard surgical burs and surgical drill bits Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All HWE devicesHWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWE
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · HWE
Too few HWE 510(k)s in any year since 2007 to give a median.
Recalls per year · HWE
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWE
2,848in 2025
MAUDE reports naming product code HWE, 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 | 1 | — | 0 | 123 |
| 2008 | 0 | — | 0 | 72 |
| 2009 | 0 | — | 4 | 180 |
| 2010 | 0 | — | 2 | 297 |
| 2011 | 1 | — | 2 | 138 |
| 2012 | 0 | — | 0 | 221 |
| 2013 | 0 | — | 1 | 1,243 |
| 2014 | 0 | — | 3 | 3,794 |
| 2015 | 1 | — | 5 | 5,567 |
| 2016 | 0 | — | 2 | 4,974 |
| 2017 | 0 | — | 1 | 5,074 |
| 2018 | 0 | — | 0 | 3,589 |
| 2019 | 0 | — | 0 | 3,452 |
| 2020 | 0 | — | 0 | 3,248 |
| 2021 | 0 | — | 0 | 3,140 |
| 2022 | 0 | — | 0 | 3,327 |
| 2023 | 0 | — | 0 | 3,397 |
| 2024 | 0 | — | 0 | 3,686 |
| 2025 | 0 | — | 0 | 2,848 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Indications for use of the surgical bur and surgical drill bit devices are situations in surgical procedures where bone, hard tissue, or soft tissue is drilled, reamed, sculpted, augmented, reduced, replaced, or removed.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972508 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972508: Surgical Burs and Surgical Drill Bits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972508
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026