# K093805: OSCAR 3

- Pathway: 510(k) (Traditional)
- Applicant: Orthosonics, Ltd.
- Decided: Feb 19, 2010 after 70 days
- Product code: JDX (Instrument, Surgical, Sonic And Accessory/Attachment)
- Device class: 2
- Regulation: 21 CFR 888.4580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K900003 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051053: Oscar, Model OE3000DB, Orthosonics, Ltd. (2005) Summary page 1.
- K083830: Oscar Bone Resector, Orthosonics, Ltd. (2009) Summary page 1.

## Indications for use
The Orthosonics OSCAR 3 is intended to be used for cutting and removal of bone and acrylic bone cement in orthopedic applications.

Source page: https://510kreport.com/device/K093805
Methodology: https://510kreport.com/methodology