510(k) · Cleared
ClearedStryker MIS Attachments and Cutting Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Cleared on May 1, 2015 as substantially equivalent to K112593 (Stryker Corporation, 2012) after a 137-day review. Its family tree reaches back 1 generation to 2012. 4 later devices descend from it.
- Decided
- May 1, 2015
- Review
- 137 days
- Class
- Class II
- Product code
- HBE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K112593 (2012). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK112593 Styker Consolidated Operating Room Equipment (Core) SystemStryker Corporation · 2012
- This deviceK143540 Stryker MIS Attachments and Cutting AccessoriesStryker Corporation · 2015
- Descendant · cites it directly · 1 of its ownK210377 Stryker iBur hubs and cutting accessoriesStryker Corporation · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK250374 iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur…Stryker Instruments · 2025
- Descendant · cites it directly · 0 of its ownK191049 Stryker MIS and Footed AttachmentsStryker Corporation · 2019
- Descendant · cites it directly · 0 of its ownK153519 DRealCarevature Medical, Ltd. · 2016
Most influential descendants
Showing 4 of 4 · See all- K210377Stryker iBur hubs and cutting accessoriesStryker Corporation · 2021 · cites it directly1descendant
- K250374iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round…Stryker Instruments · 2025 · 2 generations on0descendants
- K191049Stryker MIS and Footed AttachmentsStryker Corporation · 2019 · cites it directly0descendants
- K153519DRealCarevature Medical, Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K112593 | Styker Consolidated Operating Room Equipment (Core) System | Stryker Corporation | 2012 | — |
| 0 (this device) | K143540 | Stryker MIS Attachments and Cutting Accessories | Stryker Corporation | 2015 | — |
| +1 | K210377 | Stryker iBur hubs and cutting accessories | Stryker Corporation | 2021 | 10 |
| +2 | K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm… | Stryker Instruments | 2025 | — |
| +1 | K191049 | Stryker MIS and Footed Attachments | Stryker Corporation | 2019 | — |
| +1 | K153519 | DReal | Carevature Medical, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 HBE? 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 HBE device
- #1 K251433 Surgify Halo (54.085.SHD.H1); Surgify Halo…score 13.2 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K112593 | Styker Consolidated Operating Room Equipment (Core) SystemSummary page 5…le, p ) ERL Drill, surgical, ENT 21 CFR 1] (electric or 874.4250 (Secondary | pneumatic) including Code) handpiece 510(k) FDA Product Trade name Manufacturer number code K112593 | ERL Stryker® Consolidated | Stryker Operating Room Instruments Equipment (CORE) System 2 510(k) Summary, Rev 02 Traditional 51… | 2012 |
What descends from it? (4)
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?
How does its category compare?
All HBE devicesHBE Drills, Burrs, Trephines & Accessories (Simple, Powered): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HBE
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBE
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HBE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBE
1,924in 2025
MAUDE reports naming product code HBE, 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 | 2 | — | 0 | 14 |
| 2008 | 2 | — | 47 | 14 |
| 2009 | 0 | — | 7 | 242 |
| 2010 | 0 | — | 23 | 492 |
| 2011 | 2 | — | 1 | 1,013 |
| 2012 | 1 | — | 26 | 1,146 |
| 2013 | 1 | — | 4 | 1,583 |
| 2014 | 2 | — | 0 | 559 |
| 2015 | 3 | 155 | 0 | 483 |
| 2016 | 2 | — | 7 | 848 |
| 2017 | 2 | — | 3 | 848 |
| 2018 | 2 | — | 0 | 787 |
| 2019 | 5 | 133 | 0 | 836 |
| 2020 | 0 | — | 0 | 1,025 |
| 2021 | 6 | 193 | 1 | 1,047 |
| 2022 | 2 | — | 0 | 900 |
| 2023 | 2 | — | 3 | 948 |
| 2024 | 0 | — | 1 | 1,153 |
| 2025 | 6 | 30 | 0 | 1,924 |
| 2026 | 1 | — | 19 | — |
What is it indicated for?
The MIS Attachments and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and electric and pneumatic motors. When used with these motors, the MIS Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat…
Read the full statement (109 words)
The MIS Attachments and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and electric and pneumatic motors. When used with these motors, the MIS Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otorhinolaryngology; and Endoscopic applications.
Specific applications include Craniotomy/Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/ Anterior Skull Base/ Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine.
These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.
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/K143540 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143540: Stryker MIS Attachments and Cutting Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143540
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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