# K051053: Oscar, Model OE3000DB

- Pathway: 510(k) (Traditional)
- Applicant: Orthosonics, Ltd.
- Decided: Jul 21, 2005 after 87 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: 3 generations back to K900003 (1990). 7 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031280: Ultra-Drive 3, Biomet, Inc. (2003) Summary page 1.
- K961725: Oscar Orthosonics System for Cemented Arthroplasty Revision, C.L. Mcintosh & Assoc., Inc. (1996) Summary page 1.
- K021502: Oscar, Model OE3000, Orthosonics, Ltd. (2002) Summary page 1.

## Most influential descendants
- K083830: Oscar Bone Resector (2009), 1 descendant of its own
- K093805: OSCAR 3 (2010), 0 descendants of its own
- K072961: Lotus Ultrasonic System for Cemented Implant Extraction (Uscix) (2007), 0 descendants of its own

## Indications for use
The Orthosonics OSCAR OE300ODB is intended to be used for cutting and removal of bone and acrylic bone cement in orthopedic applications.

Source page: https://510kreport.com/device/K051053
Methodology: https://510kreport.com/methodology