510(k) · Cleared
ClearedAesculap Hilan Motor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Cleared on Dec 29, 1997 after an 89-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Dec 29, 1997
- Review
- 89 days
- Class
- Class I
- Product code
- HWE
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK973736 Aesculap Hilan Motor SystemAesculap, Inc. · 1997
- Descendant · cites it directly · 9 of its ownK980686 Aesculap Hilan Motor SystemAesculap, Inc. · 1998
- Descendant · 2 generations on · 6 of its ownK013091 ZMM 2000 Zeppelin Millennium Motordrill SystemVon Zeppelin GmbH · 2002
- Descendant · 3 generations on · 4 of its ownK130755 Hicut Highspeed InstrumentAdeor Medical AG · 2014
- Descendant · 4 generations on · 3 of its ownK232684 Surgify HaloSurgify Medical OY · 2023
- Descendant · 5 generations on · 2 of its ownK250380 Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify…Surgify Medical OY · 2025 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K980686Aesculap Hilan Motor SystemAesculap, Inc. · 1998 · cites it directly9descendants
- K013091ZMM 2000 Zeppelin Millennium Motordrill SystemVon Zeppelin GmbH · 2002 · 2 generations on6descendants
- K130755Hicut Highspeed InstrumentAdeor Medical AG · 2014 · 3 generations on4descendants
- K232684Surgify HaloSurgify Medical OY · 2023 · 4 generations on3descendants
- K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY · 2025 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973736 | Aesculap Hilan Motor System | Aesculap, Inc. | 1997 | — |
| +1 | K980686 | Aesculap Hilan Motor System | Aesculap, Inc. | 1998 | — |
| +2 | K013091 | ZMM 2000 Zeppelin Millennium Motordrill System | Von Zeppelin GmbH | 2002 | — |
| +3 | K130755 | Hicut Highspeed Instrument | Adeor Medical AG | 2014 | — |
| +4 | K232684 | Surgify Halo | Surgify Medical OY | 2023 | — |
| +5 | K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo… | Surgify Medical OY | 2025 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 HWE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | — | Aesculap pneumatic motor system Named without a submission number | |
| * | — | Anspach high-speed pneumatic system Named without a submission number | |
| * | — | Hall/Zimmer high-speed pneumatic system Named without a submission number | |
| * | — | Midas Rex high-speed pneumatic system Named without a submission number | |
| * | — | Zepplin high-speed pneumatic system Named without a submission number |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980686 | Aesculap Hilan Motor System | 1998 | 9 |
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?
- Of its descendants, K980686 (Aesculap, Inc., 1998) has gone furthest, with 9 descendants of its own.
How does its category compare?
All HWE devicesHWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWE
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · HWE
Too few HWE 510(k)s in any year since 2007 to give a median.
Recalls per year · HWE
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWE
2,848in 2025
MAUDE reports naming product code HWE, 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 | 1 | — | 0 | 123 |
| 2008 | 0 | — | 0 | 72 |
| 2009 | 0 | — | 4 | 180 |
| 2010 | 0 | — | 2 | 297 |
| 2011 | 1 | — | 2 | 138 |
| 2012 | 0 | — | 0 | 221 |
| 2013 | 0 | — | 1 | 1,243 |
| 2014 | 0 | — | 3 | 3,794 |
| 2015 | 1 | — | 5 | 5,567 |
| 2016 | 0 | — | 2 | 4,974 |
| 2017 | 0 | — | 1 | 5,074 |
| 2018 | 0 | — | 0 | 3,589 |
| 2019 | 0 | — | 0 | 3,452 |
| 2020 | 0 | — | 0 | 3,248 |
| 2021 | 0 | — | 0 | 3,140 |
| 2022 | 0 | — | 0 | 3,327 |
| 2023 | 0 | — | 0 | 3,397 |
| 2024 | 0 | — | 0 | 3,686 |
| 2025 | 0 | — | 0 | 2,848 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Aesculap’s HiLan Motor System is a high-speed pneumatic motor system intended for use in surgical procedures to drive handpieces which cut and shape bone. It is indicated for use in orthopedics, spine, and plastic/reconstructive (i.e. maxillofacial and craniofacial) procedures.
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/K973736 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973736: Aesculap Hilan Motor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973736
Report an extraction error
Are you the manufacturer?
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