# K961725: Oscar Orthosonics System for Cemented Arthroplasty Revision

- Pathway: 510(k) (Traditional)
- Applicant: C.L. Mcintosh & Assoc., Inc.
- Decided: Aug 1, 1996 after 90 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: 1 generation back to K900003 (1990). 1 ancestor in all.
8 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900003: System Ten Model 100 Surgical System, Advanced Osseous Technologies (1990) Summary page 1.

## Most influential descendants
- K021502: Oscar, Model OE3000 (2002), 7 descendants of its own
- K051053: Oscar, Model OE3000DB (2005), 3 descendants of its own
- K063531: Series 3 Lotus Laparoscopic Ultrasound Surgery System (2007), 2 descendants of its own
- K151101: Lotus Series 4 Ultrasonic Surgical System & Accessories (2015), 1 descendant of its own
- K083830: Oscar Bone Resector (2009), 1 descendant of its own

## Indications for use
The OSCAR Orthosonics System for Cemented Arthroplasty Revision is intended to assist in the removal of polymethylmethacrylate (PMMA) bone cement during arthroplasty revision.

Source page: https://510kreport.com/device/K961725
Methodology: https://510kreport.com/methodology