510(k) · Cleared
ClearedStryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Cleared on Jun 14, 2019 as substantially equivalent to K143320 (Stryker Corp., 2015) after a 133-day review. Its family tree reaches back 3 generations to 2002. 5 later devices descend from it.
- Decided
- Jun 14, 2019
- Review
- 133 days
- Class
- Class II
- Product code
- HBE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K020069 (2002). 4 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK020069 Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High…Medtronic Midas Rex · 2002 · Recalled
- 2 generations backK041754 Stryker Maestro SystemStryker Corp. · 2004
- 1 generation backK143320 Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker Corp. · 2015 · Recalled
- This deviceK190172 Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker · 2019
- Descendant · cites it directly · 4 of its ownK241171 Spine Guidance Software (Version 5.1); Consolidated Operating Room…Stryker Leibinger GmbH & Co KG · 2024
- Descendant · 2 generations on · 2 of its ownK241517 Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG · 2024
- Descendant · 2 generations on · 1 of its ownK252871 Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q…Stryker Leibinger GmbH & Co KG · 2026
- Descendant · 3 generations on · 0 of its ownK253623 Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine…Stryker Leibinger GmbH & Co KG · 2026
- Descendant · 2 generations on · 0 of its ownK243958 Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments · 2025
Most influential descendants
Showing 5 of 5 · See all- K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG · 2024 · cites it directly4descendants
- K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG · 2024 · 2 generations on2descendants
- K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG · 2026 · 2 generations on1descendant
- K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG · 2026 · 3 generations on0descendants
- K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K020069 | Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System… | Medtronic Midas Rex | 2002 | 9 |
| −2 | K041754 | Stryker Maestro System | Stryker Corp. | 2004 | — |
| −1 | K143320 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments | Stryker Corp. | 2015 | 7 |
| 0 (this device) | K190172 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments | Stryker | 2019 | — |
| +1 | K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment… | Stryker Leibinger GmbH & Co KG | 2024 | — |
| +2 | K241517 | Q Guidance System; Mako Spine System; | Stryker Leibinger GmbH & Co KG | 2024 | — |
| +2 | K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments… | Stryker Leibinger GmbH & Co KG | 2026 | — |
| +3 | K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4… | Stryker Leibinger GmbH & Co KG | 2026 | — |
| +2 | K243958 | Consolidated Operating Room Equipment (CORE) 2 Console | Stryker Instruments | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K143320 | Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsSummary page 5…: II III. PREDICATE DEVICE 510 (K) Number Product code Trade name Manufacturer K143320 HBE, HBB, ERL, Stryker® Elite and Stryker Instruments… | 2015 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2… | 2024 | 4 |
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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K241171 (Stryker Leibinger GmbH & Co KG, 2024) has gone furthest, with 4 descendants of its own.
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. 2019, 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 Elite and Heavy Duty Attachments 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 Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone and bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat…
Read the full statement (187 words)
The Elite and Heavy Duty Attachments 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 Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone and bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat (ENT)/Otology/Neurotology/Otorhinolaryngotorhinolaryngology; Craniofacial and Maxillofacial; Dental; and Endoscopic applications.
The 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.
When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut teeth in the following manner: sectioning, segmenting, splitting, fragmenting, extracting, removing, drilling, and reaming.
When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices, or the cutting of screws, metal, wires, pins, and other fixation devices in the following manner: sectioning, deburring, smoothing or shaping of metal, and removing/rounding sharp edges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190172: Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190172
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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