# K221184: ORiGO System

- Pathway: 510(k) (Traditional)
- Applicant: Bien-Air Surgery SA
- Decided: Nov 2, 2022 after 191 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002224 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083720: Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80K, Bien-Air Surgery SA (2009) Summary page 4.
- K143492: OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece, Bien-Air Surgery SA (2015) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K221184
Methodology: https://510kreport.com/methodology