510(k) Report

510(k) · Cleared

Cleared

Acryl-X II System

K930629510(k) TraditionalCleared Jan 21, 1994347-day reviewClass II21 CFR 888.4580

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

Sonokinetics, Inc. · LZV System, Cement Removal Extraction

Cleared on Jan 21, 1994 after a 347-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided
Jan 21, 1994
Review
347 days
Class
Class II
Product code
LZV
Recalls
None
Predicates
0

7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 2 descendants cleared2016: 1 descendant cleared2018: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant cleared1990200020102020
  1. This deviceK930629 Acryl-X II SystemSonokinetics, Inc. · 1994
  2. Descendant · cites it directly · 6 of its ownK990572 SonotomeSonokinetics, Inc. · 1999
  3. Descendant · 2 generations on · 4 of its ownK152699 Apollo SystemPenumbra, Inc. · 2016
  4. Descendant · 3 generations on · 2 of its ownK171332 Artemis Neuro Evacuation DevicePenumbra, Inc. · 2017
  5. Descendant · 4 generations on · 1 of its ownK201308 Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical · 2020
  6. Descendant · 5 generations on · 0 of its ownK230125 Neuroblade SystemClearmind Biomedical · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1999: 22016: 12017: 12018: 12020: 12023: 1
1999high 2 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 7 · See all
  • K990572SonotomeSonokinetics, Inc. · 1999 · cites it directly6descendants
  • K152699Apollo SystemPenumbra, Inc. · 2016 · 2 generations on4descendants
  • K171332Artemis Neuro Evacuation DevicePenumbra, Inc. · 2017 · 3 generations on2descendants
  • K201308Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical · 2020 · 4 generations on1descendant
  • K230125Neuroblade SystemClearmind Biomedical · 2023 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930629Acryl-X II SystemSonokinetics, Inc.1994—
+1K990572SonotomeSonokinetics, Inc.1999—
+2K152699Apollo SystemPenumbra, Inc.2016—
+3K171332Artemis Neuro Evacuation DevicePenumbra, Inc.2017—
+4K201308Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical2020—
+5K230125Neuroblade SystemClearmind Biomedical2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
201610
201710
201810
202010
202310
FIG. 1 — Lineage of K930629, 1994–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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

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

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K990572SonotomeSonokinetics, Inc.19996

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?

  • Of its descendants, K990572 (Sonokinetics, Inc., 1999) has gone furthest, with 6 descendants of its own.

How does its category compare?

All LZV devices

LZV System, Cement Removal Extraction: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZV

FDA has decided no LZV device since 2007.

Median 510(k) review, days · LZV

Too few LZV 510(k)s in any year since 2007 to give a median.

Recalls per year · LZV

No recall names LZV since 2007.

Adverse event reports per year · LZV

1in 2018

2007: 22008: 12017: 12018: 1
2007high 2 (2007) · low 0 (2009)2025

MAUDE reports naming product code LZV, 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
20070—02
20080—01
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Sonokinetics, Inc.

3 FDA decisions under this applicant name. See the company

  • K990572SonotomeSonokinetics, Inc. · 1999
  • K911548Acryl-X System TMSonokinetics, Inc. · 1991

Recent decisions in LZV

The LZV category page

  • K021502Oscar, Model OE3000Orthosonics, Ltd. · 2002
  • K961101Stryker Cement Removal SystemStryker Corp. · 1996
  • K904156Origin (TM) Cement Extract Syst STD-PR/SPL-PR KitsOrigin Medsystems, Inc. · 1990
  • K904180Prosthetic Cement RemoverOrigin Medsystems, Inc. · 1990
  • K891472Implant Technology Bone Cement ExtractorImplant Technology, Inc. · 1989

https://510kreport.com/device/K930629 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930629: Acryl-X II System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930629

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026