510(k) · Cleared
ClearedSynthes Sterile Drill Bits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Cleared on Nov 14, 1996 after a 111-day review. The FDA summary names no predicate by number. 10 later devices descend from it.
- Decided
- Nov 14, 1996
- Review
- 111 days
- Class
- Class I
- Product code
- HWE
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK962913 Synthes Sterile Drill BitsSynthes (Usa) · 1996
- Descendant · cites it directly · 4 of its ownK161704 Phasor DrillBiotex, Inc. · 2016 · Recalled
- Descendant · cites it directly · 3 of its ownK122455 Synthes Small External Fixation System, Synthes Large External…Synthes · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK230619 Hubly Electric Drill (H100)Hubly, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK141912 Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone…Advanced Orthopaedic Solutions, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK252696 LegacyPhasor Health, LLC · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K161704Phasor DrillBiotex, Inc. · 2016 · cites it directly4descendants
- K122455Synthes Small External Fixation System, Synthes Large External Fixation SystemSynthes · 2013 · cites it directly3descendants
- K230619Hubly Electric Drill (H100)Hubly, Inc. · 2023 · 2 generations on1descendant
- K141912Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…Advanced Orthopaedic Solutions, Inc. · 2014 · 2 generations on1descendant
- K252696LegacyPhasor Health, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962913 | Synthes Sterile Drill Bits | Synthes (Usa) | 1996 | — |
| +1 | K161704 | Phasor Drill | Biotex, Inc. | 2016 | 1 |
| +1 | K122455 | Synthes Small External Fixation System, Synthes Large External Fixation System | Synthes | 2013 | 2 |
| +2 | K230619 | Hubly Electric Drill (H100) | Hubly, Inc. | 2023 | — |
| +2 | K141912 | Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External… | Advanced Orthopaedic Solutions, Inc. | 2014 | — |
| +2 | K252696 | Legacy | Phasor Health, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 0 |
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?
The FDA summary names no predicate by number.
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- Of its descendants, K161704 (Biotex, Inc., 2016) has gone furthest, with 4 descendants of its own.
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?
Synthes Sterile Drill Bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.
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/K962913 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962913: Synthes Sterile Drill Bits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962913
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026