# K083720: Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80K

- Pathway: 510(k) (Traditional)
- Applicant: Bien-Air Surgery SA
- Decided: Mar 20, 2009 after 95 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002224 (2000). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041523: XPS 3000 System, Medtronic Xomed, Inc. (2004) Summary page 1.
- K020594: Diego Powered Dissector and Drill System, Gyrus Ent LLC (2002) Summary page 1.

## Most influential descendants
- K173066: OSSEODUO Shaver and Drill System (2018), 3 descendants of its own
- K233153: Traus SSG10 Surgical System (2024), 0 descendants of its own
- K232938: Traus SSG30 Surgical System (2024), 0 descendants of its own
- K221184: ORiGO System (2022), 0 descendants of its own
- K213697: ORiGO System (2022), 0 descendants of its own

## Recalls of this device
- Sep 11, 2020 · Class II · Z-0177-2021: The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
- Sep 11, 2020 · Class II · Z-0180-2021: The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

## Indications for use
The OSSEODUO is a drill and shaver system that has been designed for drilling and shaping bone and for the resection of soft and hard tissues as part of surgical operations in the areas of otorhinolaryngology, otoneurology, maxillofacial surgery, and head and neck surgery. The shaver handpiece S80 or S120 is designed for cutting and removal of soft and hard tissue in the fields of: - Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty) - Endoscopic dacryocystorhinostomy (DCR) - Nasopharyngeal and laryngeal prodedures (such as adenoidectomy, polypectomy, tonsillectomy) - Head and neck surgery( such as acoustic-neuroma removal, tumor removal, rhinoplasty, adipose tissue removal, plastic, reconstructive and aesthetic surgery) The micromotor 80K combines with different drill and micro saw handpieces and is intended for cutting, drilling, shaping and sawing bone as part of various surgical procedures in the areas of ENT and head and neck surgery such as otoneurology, otorhinolaryngology and maxillofacial surgery (facial plastic, reconstructive and aesthetic surgery).

Source page: https://510kreport.com/device/K083720
Methodology: https://510kreport.com/methodology