# K981636: Integrated Drive/Pump System

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Aug 20, 1998 after 104 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
479 later devices descend from it; 4 cite it directly.
1 of 480 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Universal Drive System: named in the summary without a submission number
- (no number) Hall® Irrigation System: named in the summary without a submission number
- (no number) TPS Total Performance System: named in the summary without a submission number
- (no number) Hummer 2®: named in the summary without a submission number

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

## Recalls of this device
- Aug 26, 2004 · Not classified · Z-0041-05: The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable.

## Indications for use
The Integrated Drive/Pump System functions as a powered instrument system consisting of blades, burs, bur guards, associated handpieces, drive/pump console, footswitch, shaver adapter, and irrigation tubing sets to perform resection of soft tissue and bone. The fields of application include: Otolaryngology, Neurological Surgical, Orthopedic, and Spinal surgical procedures.

Source page: https://510kreport.com/device/K981636
Methodology: https://510kreport.com/methodology