# K213697: ORiGO System

- Pathway: 510(k) (Traditional)
- Applicant: Bien-Air Surgery SA
- Decided: Oct 31, 2022 after 342 days
- Product code: HBC (Motor, Drill, Electric)
- Device class: 2
- Regulation: 21 CFR 882.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002224 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173066: OSSEODUO Shaver and Drill System, Bien-Air Surgery SA (2018) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K213697
Methodology: https://510kreport.com/methodology