510(k) Report

510(k) · Cleared

Cleared

Artisan Pulse Lavage System

K972551510(k) TraditionalCleared Oct 29, 1997113-day reviewClass II21 CFR 880.5475

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Howmedica Corp. · FQH Lavage, Jet

Cleared on Oct 29, 1997 as substantially equivalent to K790811 (Howmedica Corp., 1979) and 3 other predicates after a 113-day review. Its family tree reaches back 1 generation to 1979.

Decided
Oct 29, 1997
Review
113 days
Class
Class II
Product code
FQH
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K790811 (1979). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestor1987: 2 other ancestorsK790811 · Exeter Bone Lauage System · Howmedica Corp. · 197919751980198519901995
Other ancestors, by generation 1 generation back: 3 other ancestors K790811 · Exeter Bone Lauage System · Howmedica Corp. · 19790
  1. Root · 1 generation backK790811 Exeter Bone Lauage SystemHowmedica Corp. · 1979
  2. This deviceK972551 Artisan Pulse Lavage SystemHowmedica Corp. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K790811Exeter Bone Lauage SystemHowmedica Corp.1979—
0 (this device)K972551Artisan Pulse Lavage SystemHowmedica Corp.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198720
199510
FIG. 1 — Lineage of K972551, 1979–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FQH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FQH device

  1. #1 K253996 BD Surgiphor™ Antimicrobial Irrigation System…score 14.8 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K790811Exeter Bone Lauage System
Summary page 1
…r hose. The Artisan Pulse Lavage System is substantially equivalent to several other legally marketed devices. Examples of these are: Exeter Lavage System - Howmedica (K790811) Surgi-Lav 66 System - Stryker Corporation (Preamendment) Pulsed Irrigation/Suction System - Stryker Corporation (K873466 and K…
Howmedica Corp.1979—
*K873466Excel Pulsed Irrigation/Suction System
Summary page 1
…these are: Exeter Lavage System - Howmedica (K790811) Surgi-Lav 66 System - Stryker Corporation (Preamendment) Pulsed Irrigation/Suction System - Stryker Corporation (K873466 and K951666) Davol Simpulse Lavage System - Bard (K870915) Davol Simpulse SOLO Pulsed Lavage System - Bard OhON = For informat…
Stryker Corp.1987—
*K951666Stryker Interpulse Handpiece Set, Irrigation Tips, Splash Shields, Canal Vision Tip…
Summary page 1
…Exeter Lavage System - Howmedica (K790811) Surgi-Lav 66 System - Stryker Corporation (Preamendment) Pulsed Irrigation/Suction System - Stryker Corporation (K873466 and K951666) Davol Simpulse Lavage System - Bard (K870915) Davol Simpulse SOLO Pulsed Lavage System - Bard OhON = For information contact.…
Stryker Instruments1995—
*K870915Simpulse Arthroscopy Irrigation System
Summary page 1
…rgi-Lav 66 System - Stryker Corporation (Preamendment) Pulsed Irrigation/Suction System - Stryker Corporation (K873466 and K951666) Davol Simpulse Lavage System - Bard (K870915) Davol Simpulse SOLO Pulsed Lavage System - Bard OhON = For information contact. Margaret F. Crowe : Manager, Regulatory Affai…
C.R. Bard, Inc.1987—
*—Surgi-Lav 66 System - Stryker Corporation
Named without a submission number
—
*—Davol Simpulse SOLO Pulsed Lavage System - Bard
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 4 ancestors has a recall.

How does its category compare?

All FQH devices

FQH Lavage, Jet: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FQH

3in 2023

2007: 12009: 32011: 22012: 12015: 12016: 12020: 32021: 12022: 42023: 32026 (partial year): 2
2007high 4 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FQH

410in 2023

2009: 240 days median2020: 130 days median2022: 136 days median2023: 410 days median
2007high 410 (2023) · low 130 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FQH

2in 2019

2007: 132009: 12010: 72017: 12019: 2
2007high 13 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FQH

835in 2025

2007: 102008: 272009: 702010: 1352011: 832012: 1332013: 1342014: 1942015: 1162016: 1502017: 2432018: 3172019: 3282020: 3932021: 3982022: 1712023: 3332024: 4252025: 835
2007high 835 (2025) · low 10 (2007)2025

MAUDE reports naming product code FQH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—1310
20080—027
20093240170
20100—7135
20112—083
20121—0133
20130—0134
20140—0194
20151—0116
20161—0150
20170—1243
20180—0317
20190—2328
202031300393
20211—0398
202241360171
202334100333
20240—0425
20250—0835
20262—0—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Howmedica Corp.

393 FDA decisions under this applicant name. See the company

  • N17004/S013Surgical Simplex P Bone CementHowmedica Corp. · 2000
  • N17004/S012Surgical Simplex P Radiopaque Bone CementHowmedica Corp. · 2000
  • K983528Micro Dynamic MeshHowmedica Corp. · 1998
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 19981 recall
  • K980925Duration II Tibial Inserts-Ethylene Oxide SterilizationHowmedica Corp. · 1998

Recent decisions in FQH

The FQH category page

  • K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD) · 2026
  • K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd · 2026
  • K231023ERBEJET® 2 SystemErbe Elektromedizin GmbH · 2023
  • K220759Armis VeriCyn Wound WashArmis Biopharma, Inc. · 2023
  • K220964VERSAJET Hydrosurgery System (III)Smith & Nephew Medical Limited · 2023

https://510kreport.com/device/K972551 · printed Nov 5, 2026

Cite this page

510(k) Report. “K972551: Artisan Pulse Lavage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972551

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026