510(k) · Cleared
Recalled · Class II · 2024Stryker iBur hubs 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 Jun 30, 2021 as substantially equivalent to K143540 (Stryker Corporation, 2015) after a 141-day review. Its family tree reaches back 2 generations to 2012. 1 later device descends from it. It has been recalled 10 times.
- Decided
- Jun 30, 2021
- Review
- 141 days
- Class
- Class II
- Product code
- HBE
- Recalls
- 10
- Predicates
- 1
Its longest line of descent runs back 2 generations to K112593 (2012). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK112593 Styker Consolidated Operating Room Equipment (Core) SystemStryker Corporation · 2012
- 1 generation backK143540 Stryker MIS Attachments and Cutting AccessoriesStryker Corporation · 2015
- This deviceK210377 Stryker iBur hubs and cutting accessoriesStryker Corporation · 2021
- Descendant · cites it directly · 0 of its ownK250374 iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur…Stryker Instruments · 2025
Most influential descendants
Showing 1 of 1 · See all- K250374iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round…Stryker Instruments · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K112593 | Styker Consolidated Operating Room Equipment (Core) System | Stryker Corporation | 2012 | — |
| −1 | K143540 | Stryker MIS Attachments and Cutting Accessories | Stryker Corporation | 2015 | — |
| 0 (this device) | K210377 | Stryker iBur hubs and cutting accessories | Stryker Corporation | 2021 | — |
| +1 | K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm… | Stryker Instruments | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 13.1 · 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 |
|---|---|---|---|
| * | K143540 | Stryker MIS Attachments and Cutting AccessoriesSummary page 4…tem. Legally Marketed Predicate Device 510(k) Number Product Code Trade Name Manufacturer K143540 HBE Stryker® MIS At- Stryker Instruments tac… | 2015 |
| † | K191049 | Stryker MIS and Footed Attachments | 2019 |
| † | K143320 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments | 2015 |
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 |
|---|---|---|---|
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round… | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 24, 2024 | Class II | Z-2727-2024 | Under Investigation by firm | Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or… |
| Jul 24, 2024 | Class II | Z-2724-2024 | Under Investigation by firm | Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or… |
| Jul 24, 2024 | Class II | Z-2729-2024 | Under Investigation by firm | Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or… |
| Jul 24, 2024 | Class II | Z-2725-2024 | Under Investigation by firm | Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or… |
| Jul 24, 2024 | Class II | Z-2726-2024 | Under Investigation by firm | Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or… |
| Jul 24, 2024 | Class II | Z-2731-2024 | Under Investigation by firm | Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or… |
| Jul 24, 2024 | Class II | Z-2730-2024 | Under Investigation by firm | Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or… |
| Jul 24, 2024 | Class II | Z-2722-2024 | Under Investigation by firm | Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or… |
| Jul 24, 2024 | Class II | Z-2723-2024 | Under Investigation by firm | Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or… |
| Jul 24, 2024 | Class II | Z-2728-2024 | Under Investigation by firm | Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or… |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 6.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K250374 (Stryker Instruments, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K143540.
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. 2021, 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 iBur hubs and cutting accessories are intended to be used with the Stryker Core Consolidated Operating Room (CORE) Console and electric and pneumatic motors. When used with these motors, the iBur hubs 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 (107 words)
The iBur hubs and cutting accessories are intended to be used with the Stryker Core Consolidated Operating Room (CORE) Console and electric and pneumatic motors. When used with these motors, the iBur hubs 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/Transsphenoidal, 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 as stated in the FDA summary.
https://510kreport.com/device/K210377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210377: Stryker iBur hubs and cutting accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210377
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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