# K981269: Universal Drive System

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Jun 24, 1998 after 78 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- 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: 3 generations back to K862807 (1986). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971059: Universal Drive System, Linvatec Corp. (1997) Summary page 2.
- K895198: Hall Versipower Surgical Instrument System, Zimmer, Inc. (1989) Summary page 4.
- K951118: 3M Maxi-Driver II Electric System, 3M Company (1995) Summary page 4.

## Most influential descendants
- K012630: Reprocessed Linvatec Arthroscopic Burs (2001), 0 descendants of its own
- K012613: Reprocssed Linvatec Shavers (2001), 0 descendants of its own

## Recalls of this device
- Jul 31, 2009 · Not classified · Z-1952-2009: There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower Handpieces manufactured prior to June 1, 2008.
- Jul 31, 2009 · Not classified · Z-1951-2009: There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower I Handpieces manufactured prior to June 1, 2008.
- Jul 31, 2009 · Not classified · Z-1950-2009: There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower I Handpieces manufactured prior to June 1, 2008.

## Indications for use
The Universal Drive System functions as a powered instrument system consisting of drills, saws, and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: Orthopedic, Arthroscopic, Otolaryngological, Oral/Maxillofacial, Hand, Foot, Neuro, and Plastic/Reconstructive surgical procedures.

Source page: https://510kreport.com/device/K981269
Methodology: https://510kreport.com/methodology