510(k) · Cleared
ClearedOSSEODUO Shaver and Drill System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bien-Air Surgery SA · HBC Motor, Drill, Electric
Cleared on Jun 22, 2018 as substantially equivalent to K083720 (Bien-Air Surgery SA, 2009) and 2 other predicates after a 266-day review. Its family tree reaches back 3 generations to 2000. 3 later devices descend from it.
- Decided
- Jun 22, 2018
- Review
- 266 days
- Class
- Class II
- Product code
- HBC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K002224 (2000). 8 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK002224 XPS 3000 SystemMedtronic Xomed · 2000
- 2 generations backK041523 XPS 3000 SystemMedtronic Xomed, Inc. · 2004
- 1 generation backK083720 Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80KBien-Air Surgery SA · 2009 · Recalled
- This deviceK173066 OSSEODUO Shaver and Drill SystemBien-Air Surgery SA · 2018
- Descendant · cites it directly · 0 of its ownK233153 Traus SSG10 Surgical SystemSaeshin Precision Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK232938 Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK213697 ORiGO SystemBien-Air Surgery SA · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002224 | XPS 3000 System | Medtronic Xomed | 2000 | — |
| −2 | K041523 | XPS 3000 System | Medtronic Xomed, Inc. | 2004 | — |
| −1 | K083720 | Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80K | Bien-Air Surgery SA | 2009 | 2 |
| 0 (this device) | K173066 | OSSEODUO Shaver and Drill System | Bien-Air Surgery SA | 2018 | — |
| +1 | K233153 | Traus SSG10 Surgical System | Saeshin Precision Co., Ltd. | 2024 | — |
| +1 | K232938 | Traus SSG30 Surgical System | Saeshin Precision Co., Ltd. | 2024 | — |
| +1 | K213697 | ORiGO System | Bien-Air Surgery SA | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 2 | 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 HBC? 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 |
|---|---|---|---|
| * | K083720 | Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80KSummary page 4…Electric cranial drill motor Regulatory Class: Class II Product Code: HBC, HBE Primary Clearance: K083720 March 20, 2009 Predicate Manufacturer: Bien-Air Surgery SA Device: Trade Name: OSSEODUO Sha… | 2009 |
| * | K080802 | Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP…Summary page 4…tric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Predicate Clearance: K080802 April 30, 2008 Device(s): Manufacturer: The Anspach Effort, Inc. Trade Name: eMax 2… | 2008 |
| * | K113476 | Anspach Dissection ToolsSummary page 4…me: Electric cranial drill motor Regulatory Class: II Product Code: HBC Predicate Clearance: K113476 December 16, 2011 Device: Manufacturer: The Anspach Effort, Inc. Trade Name: Diss… | 2011 |
What descends from it? (3)
3 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 18 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 5 of the 8 ancestors have a recall of any class.
- Of its descendants, K233153 (Saeshin Precision Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K083720.
How does its category compare?
All HBC devicesHBC Motor, Drill, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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 OSSEODUO system is intended for shaping bones in spine and cranium surgical operation. Shaver handpiece is not intended for use in neurosurgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173066: OSSEODUO Shaver and Drill System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173066
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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