510(k) · Cleared
ClearedDrill Guide Attachment (PN 3105 DG) of the Sodem High Speed System (Pneumatic)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sodemsystems · HBB Motor, Drill, Pneumatic
Cleared on Nov 25, 2002 after a 70-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Nov 25, 2002
- Review
- 70 days
- Class
- Class II
- Product code
- HBB
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK023066 Drill Guide Attachment (PN 3105 DG) of the Sodem High Speed System…Sodemsystems · 2002
- Descendant · cites it directly · 0 of its ownK042974 Medicon Vipair High Speed SystemMedicon EG · 2005
Most influential descendants
Showing 1 of 1 · See all- K042974Medicon Vipair High Speed SystemMedicon EG · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023066 | Drill Guide Attachment (PN 3105 DG) of the Sodem High Speed System (Pneumatic) | Sodemsystems | 2002 | — |
| +1 | K042974 | Medicon Vipair High Speed System | Medicon EG | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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? (2)
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 |
|---|---|---|---|
| * | — | Anspach Black Max Named without a submission number | |
| * | — | Anspach Micromax Named without a submission number | |
| † | K994175 | Modification to Sodem High Speed System for Neurosurgical Use | 1999 |
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 |
|---|---|---|---|
| K042974 | Medicon Vipair High Speed System | 2005 | 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?
- Of its descendants, K042974 (Medicon EG, 2005) has gone furthest, with 0 descendants of its own.
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 Drill Guide Attachment of the Sodem High Speed System allows to make holes in adjustable depth and operate with drills and cutters in different applications and surgeries.
This attachment is intended for use in Neurology (spine and craniotomy), General Plastic surgery (median sternotomy) and Orthopedic (revision implant surgery, extremity: hand, foot...) applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023066 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023066: Drill Guide Attachment (PN 3105 DG) of the Sodem High Speed System (Pneumatic).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023066
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