# K031280: Ultra-Drive 3

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Sep 22, 2003 after 153 days
- Product code: JDX (Instrument, Surgical, Sonic And Accessory/Attachment)
- Device class: 2
- Regulation: 21 CFR 888.4580
- Recalls of this device: 3 (0 Class I)
- 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.
4 later devices descend from it; 2 cite it directly.
0 of 6 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
- K051053: Oscar, Model OE3000DB (2005), 3 descendants of its own
- 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

## Recalls of this device
- Jun 4, 2019 · Class II · Z-1963-2019: The products do not have sufficient data to support the labeled shelf life of 10 years.
- Jun 4, 2019 · Class II · Z-1962-2019: The products do not have sufficient data to support the labeled shelf life of 10 years.
- Apr 18, 2012 · Not classified · Z-1521-2012: Incorrect product picture label was on the product box.

## Indications for use
Cutting and removal of bone and acrylic bone cement in orthopedic applications

Source page: https://510kreport.com/device/K031280
Methodology: https://510kreport.com/methodology