510(k) · Cleared
ClearedSodem High Speed System for Neurosurgery & Median Sternotomy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sodem Diffusion SA · HBB Motor, Drill, Pneumatic
Cleared on Jan 22, 1997 as substantially equivalent to K922299 (Von Zeppelin Chirurgische Instrumente GmbH, 1992) and 1 other predicate after a 467-day review. Its family tree reaches back 1 generation to 1983. 1 later device descends from it.
- Decided
- Jan 22, 1997
- Review
- 467 days
- Class
- Class II
- Product code
- HBB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K831756 (1983). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K993851Sodem Perforator DriveSodemsystems · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831756 | Anspach 65,000 | The Anspach Effort, Inc. | 1983 | 1 |
| 0 (this device) | K954717 | Sodem High Speed System for Neurosurgery & Median Sternotomy | Sodem Diffusion SA | 1997 | — |
| +1 | K993851 | Sodem Perforator Drive | Sodemsystems | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (4)
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 |
|---|---|---|---|
| * | K922299 | Zeppelin Motor Drill SystemSummary page 2…ly powered saw Common/Usual Name: Surgical power system 3. PREDICATE DEVICES The SODEM HIGH SPEED SYSTEM claims equivalence to the following systems: . Zeppelin M.D.S. (K922299) . Zimmer Ultra Power System (No K Number Identified) . Anspach System 65K (K831756) . Midas Rex System (No K Number Identified)… | 1992 |
| * | K831756 | Anspach 65,000Summary page 2…EM HIGH SPEED SYSTEM claims equivalence to the following systems: . Zeppelin M.D.S. (K922299) . Zimmer Ultra Power System (No K Number Identified) . Anspach System 65K (K831756) . Midas Rex System (No K Number Identified) SODEM High Speed System 510(k) 10/11/95 Page E-1 4. DEVICE DESCRIPT… | 1983 |
| * | — | Zimmer Ultra Power System Named without a submission number | |
| * | — | Midas Rex System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993851 | Sodem Perforator Drive | 1999 | 0 |
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?
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 SODEM HIGH SPEED SYSTEM (with associated accessories/attachments) is intended for use for neurosurgery (spine and craniotomy) and median sternotomy.
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/K954717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954717: Sodem High Speed System for Neurosurgery & Median Sternotomy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954717
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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