510(k) Report

510(k) · Cleared

Cleared

Resorabplug

K920118510(k) TraditionalCleared Feb 8, 1993392-day reviewClass II21 CFR 878.3300

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

Sofamor Danek Mfg., Inc. · LZN Cement Obturator

Cleared on Feb 8, 1993 after a 392-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Feb 8, 1993
Review
392 days
Class
Class II
Product code
LZN
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 1 descendant cleared2006: 1 descendant cleared2004: 1 descendant cleared1990200020102020
  1. This deviceK920118 ResorabplugSofamor Danek Mfg., Inc. · 1993
  2. Descendant · cites it directly · 2 of its ownK011943 Impro Vise Absorbable Cement Flow RestrictorKensey Nash Corp. · 2001
  3. Descendant · 2 generations on · 0 of its ownK061465 Kmi Cement Restrictor ImplantKinetikos Medical, Inc. · 2006
  4. Descendant · 2 generations on · 0 of its ownK033953 Optimesh 500E Cement RestrictorSpineology, Inc. · 2004

Most influential descendants

Showing 3 of 3 · See all
  • K011943Impro Vise Absorbable Cement Flow RestrictorKensey Nash Corp. · 2001 · cites it directly2descendants
  • K061465Kmi Cement Restrictor ImplantKinetikos Medical, Inc. · 2006 · 2 generations on0descendants
  • K033953Optimesh 500E Cement RestrictorSpineology, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920118ResorabplugSofamor Danek Mfg., Inc.1993—
+1K011943Impro Vise Absorbable Cement Flow RestrictorKensey Nash Corp.2001—
+2K061465Kmi Cement Restrictor ImplantKinetikos Medical, Inc.2006—
+2K033953Optimesh 500E Cement RestrictorSpineology, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200410
200610
FIG. 1 — Lineage of K920118, 1993–2006Source: 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 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. #1 K220838 Artisan Bone Plug, Universal Cement Restrictorscore 11.8 · 9 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K011943Impro Vise Absorbable Cement Flow RestrictorKensey Nash Corp.20012

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, K011943 (Kensey Nash Corp., 2001) has gone furthest, with 2 descendants of its own.

How does its category compare?

All LZN devices

LZN Cement Obturator: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZN

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

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

2022: 1
2007high 1 (2022) · low 0 (2007)2026

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

Adverse event reports per year · LZN

6in 2025

2007: 12008: 22009: 32010: 72011: 32012: 132013: 42014: 302015: 412016: 62017: 62018: 82019: 112020: 112021: 122022: 62023: 132024: 72025: 6
2007high 41 (2015) · low 1 (2007)2025

MAUDE reports naming product code LZN, 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—01
20080—02
20090—03
20100—07
20110—03
20120—013
20130—04
20140—030
20150—041
20160—06
20170—06
20180—08
20190—011
20200—011
20210—012
20221—16
20230—013
20240—07
20250—06
20260—0—

More from Sofamor Danek Mfg., Inc.

23 FDA decisions under this applicant name. See the company

  • K936294Sentry (TM) Anterior/Posterior Spinal SystemsSofamor Danek Mfg., Inc. · 1995
  • K930191Danek (TM) Spinal Epidural Endoscopic SYSofamor Danek Mfg., Inc. · 1995
  • K932029TSRH Spinal ScrewsSofamor Danek Mfg., Inc. · 1995
  • K922486Danek Tissue Cutting and Removal SystemSofamor Danek Mfg., Inc. · 1993
  • K930807Sentry Anterior Spinal SystemSofamor Danek Mfg., Inc. · 1993

Recent decisions in LZN

The LZN category page

  • K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics · 2022
  • K061824Tornier Cement RestrictorTornier · 2006
  • K032685Cemstop Cement RestrictorTeknimed, S.A. · 2003
  • K023680Biobuck Cement RestrictorSmith & Nephew, Inc. · 2002
  • K011943Impro Vise Absorbable Cement Flow RestrictorKensey Nash Corp. · 2001

https://510kreport.com/device/K920118 · printed Nov 5, 2026

Cite this page

510(k) Report. “K920118: Resorabplug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K920118

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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