# K971059: Universal Drive System

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Jun 18, 1997 after 86 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- 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 K862807 (1986). 6 ancestors in all.
488 later devices descend from it; 11 cite it directly.
1 of 495 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942660: Hall Microchoice Electric Powered System, Hall Surgical, Division of Zimmer, Inc. (1994) Summary page 2.
- K944476: Apex Universal Drive System, Linvatec Corp. (1994) Summary page 2.
- K964548: Apex Universal Drive System, Linvatec Corp. (1997) Summary page 2.
- (no number) TPS Total Performance System: named in the summary without a submission number
- (no number) Adapteur Power System: named in the summary without a submission number

## Most influential descendants
- K981637: Integrated Drive/Pump System for Otolaryngology (1998), 478 descendants of its own
- K990524: E9000 System (1999), 477 descendants of its own
- K012453: Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery) (2001), 447 descendants of its own
- K012457: Sodem High Speed System (Electric) (Neuro/Spine Surgery) (2001), 447 descendants of its own
- K012456: Sodem High Speed System (Electric) (Ear, Nose, and Throat) (2001), 446 descendants of its own

## 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/K971059
Methodology: https://510kreport.com/methodology