# K972551: Artisan Pulse Lavage System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Oct 29, 1997 after 113 days
- Product code: FQH (Lavage, Jet)
- Device class: 2
- Regulation: 21 CFR 880.5475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K790811 (1979). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K790811: Exeter Bone Lauage System, Howmedica Corp. (1979) Summary page 1.
- K873466: Excel Pulsed Irrigation/Suction System, Stryker Corp. (1987) Summary page 1.
- K951666: Stryker Interpulse Handpiece Set, Irrigation Tips, Splash Shields, Canal Vision Tip, Irrigation & Suction Tips, Stryker Instruments (1995) Summary page 1.
- K870915: Simpulse Arthroscopy Irrigation System, C.R. Bard, Inc. (1987) Summary page 1.
- (no number) Surgi-Lav 66 System - Stryker Corporation: named in the summary without a submission number
- (no number) Davol Simpulse SOLO Pulsed Lavage System - Bard: named in the summary without a submission number

## Indications for use
The Artisan Pulse Lavage System is intended to be used in the preparation of the intramedullary canal and/or bone surfaces in orthopedic procedures, including primary and/or revision total joint arthroplasty. This device may also be used to provide lavage for wound/burn irrigation/debridement in trauma situations, or any other situation where irrigation may be indicated. The pulsatile action of the pump helps to remove blood, tissue debris and foreign matter from the operative/wound site. When connected to a suction source the device can be used to aspirate material/fluids from the operative/wound site.

Source page: https://510kreport.com/device/K972551
Methodology: https://510kreport.com/methodology