510(k) · Cleared
ClearedZMM 2000 Zeppelin Millennium Motordrill System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Von Zeppelin GmbH · HBB Motor, Drill, Pneumatic
Cleared on Jan 25, 2002 as substantially equivalent to K922299 (Von Zeppelin Chirurgische Instrumente GmbH, 1992) and 2 other predicates after a 130-day review. Its family tree reaches back 2 generations to 1997. 6 later devices descend from it.
- Decided
- Jan 25, 2002
- Review
- 130 days
- Class
- Class II
- Product code
- HBB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K973736 (1997). 4 ancestors in all, the oldest K922299 (1992). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK973736 Aesculap Hilan Motor SystemAesculap, Inc. · 1997
- 1 generation backK980686 Aesculap Hilan Motor SystemAesculap, Inc. · 1998
- This deviceK013091 ZMM 2000 Zeppelin Millennium Motordrill SystemVon Zeppelin GmbH · 2002
- Descendant · cites it directly · 4 of its ownK130755 Hicut Highspeed InstrumentAdeor Medical AG · 2014
- Descendant · 2 generations on · 3 of its ownK232684 Surgify HaloSurgify Medical OY · 2023
- Descendant · 3 generations on · 2 of its ownK250380 Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify…Surgify Medical OY · 2025 · Recalled
- Descendant · 4 generations on · 1 of its ownK251433 Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify…Surgify Medical OY · 2025 · Recalled
- Descendant · 5 generations on · 0 of its ownK253627 Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify…Surgify Medical OY · 2026 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K130755Hicut Highspeed InstrumentAdeor Medical AG · 2014 · cites it directly4descendants
- K232684Surgify HaloSurgify Medical OY · 2023 · 2 generations on3descendants
- K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY · 2025 · 3 generations on2descendants
- K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY · 2025 · 4 generations on1descendant
- K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo…Surgify Medical OY · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973736 | Aesculap Hilan Motor System | Aesculap, Inc. | 1997 | — |
| −1 | K980686 | Aesculap Hilan Motor System | Aesculap, Inc. | 1998 | — |
| 0 (this device) | K013091 | ZMM 2000 Zeppelin Millennium Motordrill System | Von Zeppelin GmbH | 2002 | — |
| +1 | K130755 | Hicut Highspeed Instrument | Adeor Medical AG | 2014 | — |
| +2 | K232684 | Surgify Halo | Surgify Medical OY | 2023 | — |
| +3 | K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo… | Surgify Medical OY | 2025 | 5 |
| +4 | K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo… | Surgify Medical OY | 2025 | 3 |
| +5 | K253627 | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo… | Surgify Medical OY | 2026 | 11 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 HBB? 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 HBB device
- #1 K253772 Velocity Alpha MR High Speed Surgical Drill…score 11.0 · 1 generation · no Class I recall
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K922299 | Zeppelin Motor Drill SystemSummary page 2…neurosurgical procedures. E. TECHNOLOGICAL CHARACTERISTICS The ZMM 2000 is a variation and very much similar to the old Zeppelin Motordrill System with 510(k) Number: #K922299 submitted in July 1992. F. PERFORMANCE STANDARDS No applicable performance standards have been promulgated under Section 514 of… | 1992 |
| * | K980686 | Aesculap Hilan Motor SystemSummary page 1…g ZMW-121 Wall Tubing Pneumatic Cranial Drill Motor Class |l Cranial Drill Motor Zeppelin Motordrill System (#K92229) Aesculap HilLan Motor System for Neurosurgery (#£980686) Midas Rex, Midas Rex I, Il (#950518) Komet Medical Xk —95 Perforator Motor (#991625) Black Max by Anspach 510 [k] summary as… | 1998 |
| Kept off the family tree | K950518 | FDA’s K950518 is Miele G 7781 Dental Thermal Disinfector Our OCR of the scanned summary read K950518, FDA’s number for Miele G 7781 Dental Thermal Disinfector (Miele Professional). Its FDA name has none of the distinctive words the summary uses for the device it names, “Midas Rex, Midas Rex I, II”. Kept off the family tree. Summary page 1…ial Drill Motor Class |l Cranial Drill Motor Zeppelin Motordrill System (#K92229) Aesculap HilLan Motor System for Neurosurgery (#£980686) Midas Rex, Midas Rex I, Il (#950518) Komet Medical Xk —95 Perforator Motor (#991625) Black Max by Anspach 510 [k] summary as required by section 807.92 (0) page 1/… | 1996 |
| * | K991625 | Komet XK-95 Perforator Motor (MI-102)Summary page 1…ppelin Motordrill System (#K92229) Aesculap HilLan Motor System for Neurosurgery (#£980686) Midas Rex, Midas Rex I, Il (#950518) Komet Medical Xk —95 Perforator Motor (#991625) Black Max by Anspach 510 [k] summary as required by section 807.92 (0) page 1/2 vonzZePPELI Chi 1shumente Gmi… | 1999 |
| * | — | Black Max by Anspach Named without a submission number |
What descends from it? (6)
2 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 5 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K130755 (Adeor Medical AG, 2014) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K922299.
How does its category compare?
All HBB devicesHBB Motor, Drill, Pneumatic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HBB
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · HBB
Too few HBB 510(k)s in any year since 2007 to give a median.
Recalls per year · HBB
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBB
1,016in 2025
MAUDE reports naming product code HBB, 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 | — | 1 | 82 |
| 2008 | 0 | — | 1 | 176 |
| 2009 | 1 | — | 1 | 196 |
| 2010 | 2 | — | 0 | 183 |
| 2011 | 0 | — | 0 | 399 |
| 2012 | 0 | — | 0 | 379 |
| 2013 | 0 | — | 1 | 685 |
| 2014 | 0 | — | 0 | 562 |
| 2015 | 1 | — | 1 | 440 |
| 2016 | 0 | — | 0 | 273 |
| 2017 | 1 | — | 1 | 203 |
| 2018 | 1 | — | 0 | 295 |
| 2019 | 0 | — | 0 | 284 |
| 2020 | 0 | — | 0 | 263 |
| 2021 | 0 | — | 0 | 260 |
| 2022 | 0 | — | 0 | 172 |
| 2023 | 0 | — | 0 | 180 |
| 2024 | 0 | — | 0 | 759 |
| 2025 | 0 | — | 2 | 1,016 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ,,ZMM 2000 Zeppelin Millenium Motordrill System” is a fast running (~90.000 rpm) powered surgical drill system for the rapide trepanation of bone, plastic, metal or cement with high precision. It is in particular usefull to rapidly cut bone in neurosurgical, ENT, maxillofacial and orthopedic 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/K013091 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013091: ZMM 2000 Zeppelin Millennium Motordrill System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013091
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026