510(k) · Cleared
ClearedORiGO System
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 Nov 2, 2022 as substantially equivalent to K083720 (Bien-Air Surgery SA, 2009) and 1 other predicate after a 191-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Nov 2, 2022
- Review
- 191 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002224 (2000). 5 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK221184 ORiGO SystemBien-Air Surgery SA · 2022
View 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) | K221184 | ORiGO System | Bien-Air Surgery SA | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K083720 | Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80KSummary page 4…ories 21 CFR 874.4250 Ear, nose, and throat electric or pneumatic surgical drill Class I ERL EQJ,NLY Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece K083720 dated May 20, 2009 Bien-Air Surgery SA OSSEODUO Shaver and Drill System Electrical microresector, microdebrider, shaver blades… | 2009 |
| * | K143492 | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot…Summary page 4…s, saw blades 21 CFR 874.4250 Ear, nose, and throat electric or pneumatic surgical drill Class II ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece K143492 dated March 4, 2015 Bien-Air Surgery SA OSSEOSTAP Microdrill System Electrical surgical drill, ENT drill burs 21 CFR 874.4250… | 2015 |
| † | K173066 | OSSEODUO Shaver and Drill System | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K083720.
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. 2022, 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 ORIGO system is a software-controlled motorized surgical system that includes attachments and tools for cutting soft tissue and bone and provides irrigation fluid to the surgical site.
The ORIGO system is used in the following surgical fields:
» for cutting and shaping bones and resection of soft and hard tissues in the fields of head & neck/ENT (otology, rhinology, laryngology) and maxillofacial surgeries.
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/K221184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221184: ORiGO System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221184
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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