# K021502: Oscar, Model OE3000

- Pathway: 510(k) (Special)
- Applicant: Orthosonics, Ltd.
- Decided: Jun 6, 2002 after 28 days
- Product code: LZV (System, Cement Removal Extraction)
- 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: 2 generations back to K900003 (1990). 5 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961725: Oscar Orthosonics System for Cemented Arthroplasty Revision, C.L. Mcintosh & Assoc., Inc. (1996) Summary page 1.
- K914084: Endoscopes, Precise Optics (1992) Summary page 1.
- K903458: Precision Optics Image Coupler, Precise Optics (1990) Summary page 1.
- K961101: Stryker Cement Removal System, Stryker Corp. (1996) Summary page 1.

## Most influential descendants
- 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
- K221102: LOTUS Series 4 Enhanced Shears, LOTUS Series 5 (2022), 0 descendants of its own

## Indications for use
The OE3000 is intended to assist in the removal of polymethylmethacrylate (PMMA) bone cement during arthroplasty revision.

Source page: https://510kreport.com/device/K021502
Methodology: https://510kreport.com/methodology