510(k) · Cleared
ClearedImpro Vise Absorbable Cement Flow Restrictor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kensey Nash Corp. · LZN Cement Obturator
Cleared on Sep 19, 2001 as substantially equivalent to K920118 (Sofamor Danek Mfg., Inc., 1993) after a 90-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Sep 19, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- LZN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920118 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK920118 ResorabplugSofamor Danek Mfg., Inc. · 1993
- This deviceK011943 Impro Vise Absorbable Cement Flow RestrictorKensey Nash Corp. · 2001
- Descendant · cites it directly · 0 of its ownK061465 Kmi Cement Restrictor ImplantKinetikos Medical, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK033953 Optimesh 500E Cement RestrictorSpineology, Inc. · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920118 | Resorabplug | Sofamor Danek Mfg., Inc. | 1993 | — |
| 0 (this device) | K011943 | Impro Vise Absorbable Cement Flow Restrictor | Kensey Nash Corp. | 2001 | — |
| +1 | K061465 | Kmi Cement Restrictor Implant | Kinetikos Medical, Inc. | 2006 | — |
| +1 | K033953 | Optimesh 500E Cement Restrictor | Spineology, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
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 LZN? 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 LZN device
- #1 K220838 Artisan Bone Plug, Universal Cement Restrictorscore 11.8 · 9 generations · no Class I recall
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K920118 | ResorabplugSummary page 1…e nearly identical and thus substantially equivalent to the Resorbaplug™ Bone Plug cleared by 510(k) for Danek Group (now the Sofamor Danek division of Medtronic, Inc.) (K920118). See Table 1 below for a comparison of the two devices. ‘Revised December 12, 2001. Page 1 of 2 Table 1: Subst… | 1993 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K061465 (Kinetikos Medical, Inc., 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LZN devicesLZN Cement Obturator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LZN
Too few LZN 510(k)s in any year since 2007 to give a median.
Recalls per year · LZN
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZN
6in 2025
MAUDE reports naming product code LZN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 13 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 30 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 1 | — | 1 | 6 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ImproVise™ Absorbable Cement Flow Restrictor is intended for use as an absorbable bone cement flow restrictor plug for use in the intramedullary canal. This device is not intended for use in the spine,
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011943: Impro Vise Absorbable Cement Flow Restrictor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011943
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026