510(k) · Cleared
Recalled · Class II · 2020OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece
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 4, 2015 as substantially equivalent to K041523 (Medtronic Xomed, Inc., 2004) after an 86-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 4, 2015
- Review
- 86 days
- Class
- Class II
- Product code
- ERL
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002224 (2000). 2 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 deviceK143492 OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP…Bien-Air Surgery SA · 2015
- Descendant · cites it directly · 0 of its ownK221184 ORiGO SystemBien-Air Surgery SA · 2022
- Descendant · cites it directly · 0 of its ownK161376 DragonFly Surgical Drill SystemGrace Medical, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView 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) | K143492 | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control… | Bien-Air Surgery SA | 2015 | — |
| +1 | K221184 | ORiGO System | Bien-Air Surgery SA | 2022 | — |
| +1 | K161376 | DragonFly Surgical Drill System | Grace Medical, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2022 | 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 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? (1)
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 4…tronic Xomed Inc. Oto-Tool Drill Drill, Surgical, ENT (electric or pneumatic) including handpiece. Covered by K041523 Substantial equivalence is claimed to the skeeter OTO-Tool drill, which is an accessory to the XPS3000 console, which is the su… | 2004 |
| † | K792159 | Fisch Drill System | 1979 |
What descends from it? (2)
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-0179-2021 | 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-0178-2021 | 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 15 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K221184 (Bien-Air Surgery SA, 2022) has gone furthest, with 0 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. 2015, 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 OSSEOSTAP system has been designed for the light drilling of bones as part of surgical operations such as
stapedotomy or ossiculoplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143492: OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143492
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