510(k) · Cleared
ClearedSodem High Speed System (Electric) (Neuro/Spine Surgery)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sodemsystems · HBC Motor, Drill, Electric
Cleared on Oct 22, 2001 as substantially equivalent to K943541 (Stryker Corp., 1995) and 2 other predicates after an 82-day review. Its family tree reaches back 5 generations to 1986. 1 of the 466 devices in its family, counting itself, has a Class I recall. 447 later devices descend from it.
- Decided
- Oct 22, 2001
- Review
- 82 days
- Class
- Class II
- Product code
- HBC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K862807 (1986). 18 ancestors in all, the oldest K852143 (1985). 447 later devices descend from it, 4 citing it directly. 1 of the 466 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 4 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 3 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 2 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 1 generation backK990524 E9000 SystemLinvatec Corp. · 1999
- This deviceK012457 Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001
- Descendant · cites it directly · 443 of its ownK081475 Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System…Medtronic Xomed, Inc. · 2008 · Recalled
- Descendant · cites it directly · 420 of its ownK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 418 of its ownK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 404 of its ownK124004 Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy…Medtronic Navigation, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 398 of its ownK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
Showing 5 of 447 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 447 · See all- K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · cites it directly443descendants
- K081277XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc)Medtronic Xomed, Inc. · 2008 · cites it directly420descendants
- K111520Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · 2 generations on418descendants
- K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc. · 2013 · 3 generations on404descendants
- K123270Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013 · 3 generations on398descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −4 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −3 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −2 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −1 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| 0 (this device) | K012457 | Sodem High Speed System (Electric) (Neuro/Spine Surgery) | Sodemsystems | 2001 | — |
| +1 | K081475 | Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System… | Medtronic Xomed, Inc. | 2008 | 3 |
| +1 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| +2 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| +3 | K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps | Medtronic Navigation, Inc. | 2013 | 1 |
| +3 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 7 | 0 |
| 2016 | 8 | 0 |
| 2017 | 15 | 0 |
| 2018 | 17 | 0 |
| 2019 | 26 | 0 |
| 2020 | 23 | 0 |
| 2021 | 43 | 1 |
| 2022 | 47 | 0 |
| 2023 | 63 | 0 |
| 2024 | 64 | 0 |
| 2025 | 65 | 0 |
| 2026 | 56 | 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.
1 device in this family has a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K943541 | 75K Staight DrillSummary page 1…ystem (Electric) Powered Surgical Drill The Sodem High Speed System (Electric) claims equivalence to the following systems: - Stryker: Total Performance System (TPS) (K943541) - Linvatec: E9000/Advantage (K990524 / K002523) SODEM HIGH SPEED SYSTEM (ELECTRIC) 510(K) (NEURO/SPINE SURGERY) 20/07/01 APPEN… | 1995 |
| * | K990524 | E9000 SystemSummary page 1…ll The Sodem High Speed System (Electric) claims equivalence to the following systems: - Stryker: Total Performance System (TPS) (K943541) - Linvatec: E9000/Advantage (K990524 / K002523) SODEM HIGH SPEED SYSTEM (ELECTRIC) 510(K) (NEURO/SPINE SURGERY) 20/07/01 APPENDIX F 1/4 510(k) SUMMA… | 1999 |
| * | K002523 | Advantage Drive SystemSummary page 1…dem High Speed System (Electric) claims equivalence to the following systems: - Stryker: Total Performance System (TPS) (K943541) - Linvatec: E9000/Advantage (K990524 / K002523) SODEM HIGH SPEED SYSTEM (ELECTRIC) 510(K) (NEURO/SPINE SURGERY) 20/07/01 APPENDIX F 1/4 510(k) SUMMARY FOR SOD… | 2000 |
What descends from it? (447)
See all 4474 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081475 | Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power… | 2008 | 443 |
| K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | 2008 | 420 |
| K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw… | 2017 | 11 |
| K022986 | The Bioplate Battery Powered Drill | 2002 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K081475 (Medtronic Xomed, Inc., 2008) has gone furthest, with 443 descendants of its own.
- 6 other devices also cite its predicate K943541.
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?
The Sodem High Speed motor allows the fixation of spindles and craniotomes, which operate with drills, burs and cutters for drilling, cutting and sculpting the cranial and spinal bones. The Sodem High Speed System (Electric) includes a skull perforator motor, which powers a cranial perforation attachment and allows skull perforation. The System does not include the cranial perforation attachment. The safety of the skull perforation depends exclusively on…
Read the full statement (109 words)
The Sodem High Speed motor allows the fixation of spindles and craniotomes, which
operate with drills, burs and cutters for drilling, cutting and sculpting the cranial and
spinal bones.
The Sodem High Speed System (Electric) includes a skull perforator motor, which
powers a cranial perforation attachment and allows skull perforation. The System
does not include the cranial perforation attachment. The safety of the skull perforation
depends exclusively on the safety of the cranial perforation attachment, which is
neither manufactured nor sold by Sodem, but is available on the market from other
manufacturers.
Both motors, attachments and cutting tools are for use in neurosurgery, as well
craniotomy as spinal surgery.
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/K012457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012457: Sodem High Speed System (Electric) (Neuro/Spine Surgery).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012457
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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