510(k) · Cleared
ClearedELAN 4 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 Jul 22, 2016 as substantially equivalent to K053526 (Aesculap, Inc., 2006) after a 289-day review. Its family tree reaches back 2 generations to 1994. 3 later devices descend from it.
- Decided
- Jul 22, 2016
- Review
- 289 days
- Class
- Class II
- Product code
- HBC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K943589 (1994). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK943589 Stryker Total Performance SystemStryker Corp. · 1994
- 1 generation backK053526 Microspeed Uni Motor SystemAesculap, Inc. · 2006 · Recalled
- This deviceK152960 ELAN 4 Motor SystemAesculap, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK203739 ELAN 4 Electro Motor SystemAesculap, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK191479 Velocity Alpha Highspeed Surgical Drill SystemAdeor Medical AG · 2021
- Descendant · cites it directly · 0 of its ownK172907 ELAN 4 Air Motor SystemAesculap, Inc. · 2018 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943589 | Stryker Total Performance System | Stryker Corp. | 1994 | — |
| −1 | K053526 | Microspeed Uni Motor System | Aesculap, Inc. | 2006 | 1 |
| 0 (this device) | K152960 | ELAN 4 Motor System | Aesculap, Inc. | 2016 | — |
| +1 | K203739 | ELAN 4 Electro Motor System | Aesculap, Inc. | 2021 | — |
| +1 | K191479 | Velocity Alpha Highspeed Surgical Drill System | Adeor Medical AG | 2021 | — |
| +1 | K172907 | ELAN 4 Air Motor System | Aesculap, Inc. | 2018 | 2 |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 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 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? (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 |
|---|---|---|---|
| * | K053526 | Microspeed Uni Motor SystemSummary page 4…T CODE: HBE SUBSTANTIAL EQUIVALENCE The ELAN 4 Electro Motor System is substantially equivalent to Aesculap's Microspeed Uni Motor System cleared via K053526. DEVICE DESCRIPTION The ELAN 4 Electro motor system is an electrical motor system consisting of a control unit with different si… | 2006 |
What descends from it? (3)
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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 11.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K203739 (Aesculap, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K053526.
How does its category compare?
All HBC devicesHBC Motor, Drill, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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?
The ELAN 4 Electro Motor System is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152960: ELAN 4 Motor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152960
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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