510(k) · Cleared
Recalled · 2010Microspeed Uni Motor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · HBC Motor, Drill, Electric
Cleared on Jan 18, 2006 as substantially equivalent to K003612 (Aesculap, Inc., 2001) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1994. 12 later devices descend from it. It has been recalled once.
- Decided
- Jan 18, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- HBC
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K943589 (1994). 2 ancestors in all. 12 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK943589 Stryker Total Performance SystemStryker Corp. · 1994
- This deviceK053526 Microspeed Uni Motor SystemAesculap, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK132264 PRIMADO2 Total Surgical SystemNakanishi, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK152960 ELAN 4 Motor SystemAesculap, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK233638 VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK213221 AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH · 2022
- Descendant · 2 generations on · 1 of its ownK202120 P300 AttachmentNakanishi, Inc. · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K132264PRIMADO2 Total Surgical SystemNakanishi, Inc. · 2013 · cites it directly6descendants
- K152960ELAN 4 Motor SystemAesculap, Inc. · 2016 · cites it directly3descendants
- K233638VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024 · 2 generations on1descendant
- K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH · 2022 · 2 generations on1descendant
- K202120P300 AttachmentNakanishi, Inc. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943589 | Stryker Total Performance System | Stryker Corp. | 1994 | — |
| 0 (this device) | K053526 | Microspeed Uni Motor System | Aesculap, Inc. | 2006 | — |
| +1 | K132264 | PRIMADO2 Total Surgical System | Nakanishi, Inc. | 2013 | — |
| +1 | K152960 | ELAN 4 Motor System | Aesculap, Inc. | 2016 | — |
| +2 | K233638 | VERZA™ High Speed Drills | Globus Medical, Inc. | 2024 | — |
| +2 | K213221 | AMADEO, M-UK1015 (incl. attachments and accessories) | W&H Dentalwerk Buermoss GmbH | 2022 | — |
| +2 | K202120 | P300 Attachment | Nakanishi, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 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 HBC? 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 HBC device
- #1 K254174 Surgical Power Systemscore 14.7 · 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? (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 |
|---|---|---|---|
| * | K003612 | Microspeed EC Motorsystem GD650/GD653Summary page 1…HBC SUBSTANTIAL EQUIVALENCE Aesculap®~, Inc. believes that the Microspeed Uni Motor System is substantially equivalent to: * Aesculap Microspeed EC (K003612) * Stryker Total Performance System (K943589) DEVICE DESCRIPTION The Microspeed Uni is an electronrc, high-speed motor system… | 2001 |
| * | K943589 | Stryker Total Performance SystemSummary page 1…sculap®~, Inc. believes that the Microspeed Uni Motor System is substantially equivalent to: * Aesculap Microspeed EC (K003612) * Stryker Total Performance System (K943589) DEVICE DESCRIPTION The Microspeed Uni is an electronrc, high-speed motor system, which allows high-speed dissection up to 80,00… | 1994 |
What descends from it? (12)
See all 123 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 22, 2010 | Not classified | Z-1474-2011 | Software design | Potential safety issue in that the control box can misinterpret the information sent from the low speed motor if the control magnet inside the motor changes its posthion. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HBC devicesHBC Motor, Drill, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HBC
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HBC
Too few HBC 510(k)s in any year since 2007 to give a median.
Recalls per year · HBC
9in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBC
635in 2025
MAUDE reports naming product code HBC, 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 | 0 | — | 0 | 5 |
| 2008 | 1 | — | 0 | 6 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 9 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 10,670 |
| 2014 | 1 | — | 1 | 2,643 |
| 2015 | 0 | — | 0 | 1,953 |
| 2016 | 1 | — | 0 | 2,541 |
| 2017 | 2 | — | 0 | 2,079 |
| 2018 | 1 | — | 0 | 1,779 |
| 2019 | 1 | — | 0 | 1,703 |
| 2020 | 0 | — | 0 | 1,304 |
| 2021 | 1 | — | 0 | 946 |
| 2022 | 2 | — | 9 | 760 |
| 2023 | 0 | — | 0 | 663 |
| 2024 | 2 | — | 0 | 427 |
| 2025 | 0 | — | 0 | 635 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Aesculap's Microspeed Uni is intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053526 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053526: Microspeed Uni Motor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053526
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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