# K990524: E9000 System

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Jul 15, 1999 after 146 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: 4 generations back to K862807 (1986). 15 ancestors in all.
477 later devices descend from it; 11 cite it directly.
1 of 493 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981636: Integrated Drive/Pump System, Linvatec Corp. (1998) Summary page 4.
- K981637: Integrated Drive/Pump System for Otolaryngology, Linvatec Corp. (1998) Summary page 4.
- K971059: Universal Drive System, Linvatec Corp. (1997) Summary page 4.
- K862474: Hall Sternum Saw, Hall Surgical, Division of Zimmer, Inc. (1986) Summary page 4.

## Most influential descendants
- 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
- K081475: Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)] (2008), 443 descendants of its own
- K081277: XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) (2008), 420 descendants of its own

## Indications for use
The E9000 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, Medial Sternotomy, Spinal and Plastic/Reconstructive surgical procedures.

Source page: https://510kreport.com/device/K990524
Methodology: https://510kreport.com/methodology