# K173066: OSSEODUO Shaver and Drill System

- Pathway: 510(k) (Traditional)
- Applicant: Bien-Air Surgery SA
- Decided: Jun 22, 2018 after 266 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: 3 generations back to K002224 (2000). 8 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 12 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.
- K080802: Emax 2 Plus System, Model Emax 2 Plus Motor, Emax  2 Console>Firmware Upgrade, Emax 2 FP Foot Pedal, The Anspach Effort, Inc. (2008) Summary page 4.
- K113476: Anspach Dissection Tools, The Anspach Effort, Inc. (2011) Summary page 4.

## Most influential descendants
- K233153: Traus SSG10 Surgical System (2024), 0 descendants of its own
- K232938: Traus SSG30 Surgical System (2024), 0 descendants of its own
- K213697: ORiGO System (2022), 0 descendants of its own

## Indications for use
The OSSEODUO system is intended for shaping bones in spine and cranium surgical operation. Shaver handpiece is not intended for use in neurosurgical procedures.

Source page: https://510kreport.com/device/K173066
Methodology: https://510kreport.com/methodology