510(k) · Cleared
Recalled · Class II · 2020Stryker Disposable Cranial Perforator Bit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Ireland Ltd., Instruments Division · HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)
Cleared on Dec 29, 2008 as substantially equivalent to K892866 (Acra Cut, Inc., 1989) and 1 other predicate after a 167-day review. Its family tree reaches back 2 generations to 1979. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 29, 2008
- Review
- 167 days
- Class
- Class II
- Product code
- HBF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K791101 (1979). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK791101 Disposable Perforators, Jacobs, HudsonCodman & Shurtleff, Inc. · 1979
- 1 generation backK071931 Codman Disposable Perforator, Model (S) 26-1222, 26-1223Codman & Shurtleff, Inc. · 2007
- This deviceK082010 Stryker Disposable Cranial Perforator BitStryker Ireland Ltd., Instruments Division · 2008
- Descendant · cites it directly · 0 of its ownK141455 Easydrill Autostop Cranial PerforatorMicromar Ind. Com., Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K141455Easydrill Autostop Cranial PerforatorMicromar Ind. Com., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K791101 | Disposable Perforators, Jacobs, Hudson | Codman & Shurtleff, Inc. | 1979 | — |
| −1 | K071931 | Codman Disposable Perforator, Model (S) 26-1222, 26-1223 | Codman & Shurtleff, Inc. | 2007 | — |
| 0 (this device) | K082010 | Stryker Disposable Cranial Perforator Bit | Stryker Ireland Ltd., Instruments Division | 2008 | — |
| +1 | K141455 | Easydrill Autostop Cranial Perforator | Micromar Ind. Com., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 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 HBF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HBF device
- #1 K231403 evoDrill Cranial Perforatorscore 13.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K892866 | Automatic Cranial Drill (Perforator)Summary page 1…Cranial Perforator Classification Name: Drills, Burs, Trephines & Accessories (Compound, Powered) (HBF) Equivalent to: K892866 Acra-Cut Automatic Cranial Drill (Perforator) K07 1931 Codman Disposable Perforator Device… | 1989 |
| * | K071931 | Codman Disposable Perforator, Model (S) 26-1222, 26-1223Summary page 1…& Accessories (Compound, Powered) (HBF) Equivalent to: K892866 Acra-Cut Automatic Cranial Drill (Perforator) K07 1931 Codman Disposable Perforator Device Description: The Zyphr TM Disposable Cranial Perforator is a mechanically po… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141455 | Easydrill Autostop Cranial Perforator | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 16, 2020 | Class II | Z-0431-2021 | Nonconforming Material/Component | Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 28.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K141455 (Micromar Ind. Com., Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K892866.
How does its category compare?
All HBF devicesHBF Drills, Burrs, Trephines & Accessories (Compound, Powered): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HBF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HBF
103in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HBF
2in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · HBF
113in 2025
MAUDE reports naming product code HBF, 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 | 25 |
| 2008 | 3 | 103 | 0 | 41 |
| 2009 | 0 | — | 0 | 34 |
| 2010 | 0 | — | 0 | 73 |
| 2011 | 0 | — | 1 | 39 |
| 2012 | 1 | — | 0 | 79 |
| 2013 | 0 | — | 0 | 103 |
| 2014 | 0 | — | 0 | 95 |
| 2015 | 1 | — | 0 | 59 |
| 2016 | 0 | — | 0 | 76 |
| 2017 | 0 | — | 0 | 106 |
| 2018 | 0 | — | 0 | 136 |
| 2019 | 1 | — | 0 | 208 |
| 2020 | 0 | — | 1 | 324 |
| 2021 | 0 | — | 0 | 309 |
| 2022 | 1 | — | 0 | 148 |
| 2023 | 0 | — | 0 | 108 |
| 2024 | 1 | — | 0 | 179 |
| 2025 | 0 | — | 2 (2) | 113 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Stryker Zyphr TM Disposable Cranial Perforator Large 14/11mm (perforator) is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. It is intended for thin bone that is at least 3mm thick.
The Stryker Zyphr TM Disposable Cranial Perforator Small 11/7mm (perforator) is a sterile, single use cutting accessory intended for cutting a 7 mm diameter access hole through the cranium of adult and pediatric patients. It is intended for thin bone that is at least 1mm thick.
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/K082010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082010: Stryker Disposable Cranial Perforator Bit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082010
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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