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 · HBC Motor, Drill, Electric
Cleared on Oct 31, 2022 as substantially equivalent to K173066 (Bien-Air Surgery SA, 2018) after a 342-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Oct 31, 2022
- Review
- 342 days
- Class
- Class II
- Product code
- HBC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002224 (2000). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK002224 XPS 3000 SystemMedtronic Xomed · 2000
- 3 generations backK041523 XPS 3000 SystemMedtronic Xomed, Inc. · 2004
- 2 generations backK083720 Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80KBien-Air Surgery SA · 2009 · Recalled
- 1 generation backK173066 OSSEODUO Shaver and Drill SystemBien-Air Surgery SA · 2018
- This deviceK213697 ORiGO SystemBien-Air Surgery SA · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002224 | XPS 3000 System | Medtronic Xomed | 2000 | — |
| −3 | K041523 | XPS 3000 System | Medtronic Xomed, Inc. | 2004 | — |
| −2 | K083720 | Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80K | Bien-Air Surgery SA | 2009 | 2 |
| −1 | K173066 | OSSEODUO Shaver and Drill System | Bien-Air Surgery SA | 2018 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K173066 | OSSEODUO Shaver and Drill SystemSummary page 4…HBE Classification Name: Motor, Drill, Electric Predicate Device: Clearance: K173066 dated June 22, 2018 Manufacturer: Bien-Air Surgery SA… | 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.
- 5 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K173066.
How does its category compare?
All HBC devicesHBC Motor, Drill, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 ORiGO System is a software-controlled motorized surgical system that includes attachments and tools for cutting bone, and provides irrigation fluid to the surgical site.
The ORiGO System is used in the following surgical fields:
* For cutting bones in neuro (cranial) and spinal surgeries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213697: 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/K213697
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