# K143492: OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Bien-Air Surgery SA
- Decided: Mar 4, 2015 after 86 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). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 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 4.

## Most influential descendants
- K221184: ORiGO System (2022), 0 descendants of its own
- K161376: DragonFly Surgical Drill System (2016), 0 descendants of its own

## Recalls of this device
- Sep 11, 2020 · Class II · Z-0179-2021: 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-0178-2021: The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

## Indications for use
The OSSEOSTAP system has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty.

Source page: https://510kreport.com/device/K143492
Methodology: https://510kreport.com/methodology