510(k) · Cleared
Recalled · Class II · 2020Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80K
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bien-Air Surgery SA · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Mar 20, 2009 as substantially equivalent to K041523 (Medtronic Xomed, Inc., 2004) and 1 other predicate after a 95-day review. Its family tree reaches back 2 generations to 2000. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 20, 2009
- Review
- 95 days
- Class
- Class II
- Product code
- ERL
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002224 (2000). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002224 XPS 3000 SystemMedtronic Xomed · 2000
- 1 generation backK041523 XPS 3000 SystemMedtronic Xomed, Inc. · 2004
- This deviceK083720 Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80KBien-Air Surgery SA · 2009
- Descendant · cites it directly · 3 of its ownK173066 OSSEODUO Shaver and Drill SystemBien-Air Surgery SA · 2018
- Descendant · 2 generations on · 0 of its ownK233153 Traus SSG10 Surgical SystemSaeshin Precision Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK232938 Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK221184 ORiGO SystemBien-Air Surgery SA · 2022
- Descendant · 2 generations on · 0 of its ownK213697 ORiGO SystemBien-Air Surgery SA · 2022
Most influential descendants
Showing 5 of 5 · See all- K173066OSSEODUO Shaver and Drill SystemBien-Air Surgery SA · 2018 · cites it directly3descendants
- K233153Traus SSG10 Surgical SystemSaeshin Precision Co., Ltd. · 2024 · 2 generations on0descendants
- K232938Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd. · 2024 · 2 generations on0descendants
- K221184ORiGO SystemBien-Air Surgery SA · 2022 · cites it directly0descendants
- K213697ORiGO SystemBien-Air Surgery SA · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002224 | XPS 3000 System | Medtronic Xomed | 2000 | — |
| −1 | K041523 | XPS 3000 System | Medtronic Xomed, Inc. | 2004 | — |
| 0 (this device) | K083720 | Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80K | Bien-Air Surgery SA | 2009 | — |
| +1 | K173066 | OSSEODUO Shaver and Drill System | Bien-Air Surgery SA | 2018 | — |
| +2 | K233153 | Traus SSG10 Surgical System | Saeshin Precision Co., Ltd. | 2024 | — |
| +2 | K232938 | Traus SSG30 Surgical System | Saeshin Precision Co., Ltd. | 2024 | — |
| +1 | K221184 | ORiGO System | Bien-Air Surgery SA | 2022 | — |
| +2 | K213697 | ORiGO System | Bien-Air Surgery SA | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 2 | 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 ERL? 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 ERL device
- #1 K243280 Piezomed Pro (Piezomed Pro module M-PM100…score 12.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K041523 | XPS 3000 SystemSummary page 1…Manufacturer FDA Clearance XPS 3000 System Medtronic Xomed Inc. K041523 Diego powered Dissector and Drill Gyrus ENT L.L. K020594 System… | 2004 |
| * | K020594 | Diego Powered Dissector and Drill SystemSummary page 1…System Medtronic Xomed Inc. K041523 Diego powered Dissector and Drill Gyrus ENT L.L. K020594 System A member of the Bien-Ai… | 2002 |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 11, 2020 | Class II | Z-0177-2021 | Process control | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. |
| Sep 11, 2020 | Class II | Z-0180-2021 | Process control | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K173066 (Bien-Air Surgery SA, 2018) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K041523.
How does its category compare?
All ERL devicesERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ERL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ERL
191in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ERL
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ERL
1,469in 2025
MAUDE reports naming product code ERL, 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 | 112 |
| 2008 | 6 | 181 | 0 | 60 |
| 2009 | 1 | — | 1 | 249 |
| 2010 | 0 | — | 0 | 444 |
| 2011 | 0 | — | 0 | 1,068 |
| 2012 | 2 | — | 0 | 1,379 |
| 2013 | 2 | — | 3 | 3,231 |
| 2014 | 1 | — | 0 | 1,975 |
| 2015 | 3 | 86 | 0 | 2,630 |
| 2016 | 4 | 180 | 0 | 1,455 |
| 2017 | 2 | — | 0 | 999 |
| 2018 | 1 | — | 0 | 1,380 |
| 2019 | 1 | — | 0 | 2,515 |
| 2020 | 1 | — | 5 | 2,369 |
| 2021 | 1 | — | 1 | 2,283 |
| 2022 | 3 | 191 | 0 | 1,574 |
| 2023 | 0 | — | 0 | 1,725 |
| 2024 | 1 | — | 0 | 1,588 |
| 2025 | 1 | — | 0 | 1,469 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OSSEODUO is a drill and shaver system that has been designed for drilling and shaping bone and for the resection of soft and hard tissues as part of surgical operations in the areas of otorhinolaryngology, otoneurology, maxillofacial surgery, and head and neck surgery. The shaver handpiece S80 or S120 is designed for cutting and removal of soft and hard tissue in the fields of: - Endoscopic sinus surgery (such as ethmoidectomy, polypectomy…
Read the full statement (158 words)
The OSSEODUO is a drill and shaver system that has been designed for drilling and shaping
bone and for the resection of soft and hard tissues as part of surgical operations in the areas of
otorhinolaryngology, otoneurology, maxillofacial surgery, and head and neck surgery.
The shaver handpiece S80 or S120 is designed for cutting and removal of soft and hard tissue
in the fields of:
- Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty)
- Endoscopic dacryocystorhinostomy (DCR)
- Nasopharyngeal and laryngeal prodedures (such as adenoidectomy, polypectomy,
tonsillectomy)
- Head and neck surgery( such as acoustic-neuroma removal, tumor removal,
rhinoplasty, adipose tissue removal, plastic, reconstructive and aesthetic surgery)
The micromotor 80K combines with different drill and micro saw handpieces and is intended
for cutting, drilling, shaping and sawing bone as part of various surgical procedures in the
areas of ENT and head and neck surgery such as otoneurology, otorhinolaryngology and
maxillofacial surgery (facial plastic, reconstructive and aesthetic surgery).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083720 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083720: Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083720
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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