510(k) Report

510(k) · Cleared

Cleared

Polyethylene Medullary Plug - Stiihmer/

K830949510(k) TraditionalCleared Apr 12, 198319-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

Allo Pro Corp. · LZN Cement Obturator

Cleared on Apr 12, 1983 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Apr 12, 1983
Review
19 days
Class
Class II
Product code
LZN
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2006: 1 descendant cleared2005: 1 descendant cleared19801990200020102020
  1. This deviceK830949 Polyethylene Medullary Plug - Stiihmer/Allo Pro Corp. · 1983
  2. Descendant · cites it directly · 1 of its ownK022729 Vented Cement RestrictorAmedica Corp. · 2002
  3. Descendant · cites it directly · 0 of its ownK061824 Tornier Cement RestrictorTornier · 2006
  4. Descendant · 2 generations on · 0 of its ownK050699 Modification to: Vented Cement Restrictor, Model 60102-000-001/004Amedica Corp. · 2005

Most influential descendants

Showing 3 of 3 · See all
  • K022729Vented Cement RestrictorAmedica Corp. · 2002 · cites it directly1descendant
  • K061824Tornier Cement RestrictorTornier · 2006 · cites it directly0descendants
  • K050699Modification to: Vented Cement Restrictor, Model 60102-000-001/004Amedica Corp. · 2005 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K830949Polyethylene Medullary Plug - Stiihmer/Allo Pro Corp.1983—
+1K022729Vented Cement RestrictorAmedica Corp.2002—
+1K061824Tornier Cement RestrictorTornier2006—
+2K050699Modification to: Vented Cement Restrictor, Model 60102-000-001/004Amedica Corp.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200510
200610
FIG. 1 — Lineage of K830949, 1983–2006Source: 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022729Vented Cement RestrictorAmedica Corp.20021
K061824Tornier Cement RestrictorTornier20060

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, K022729 (Amedica Corp., 2002) has gone furthest, with 1 descendant 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 Allo Pro Corp.

16 FDA decisions under this applicant name. See the company

  • K901581GSB ElbowAllo Pro Corp. · 1990
  • K900425Surgical Cotton GlovesAllo Pro Corp. · 1990
  • K900392Centering PlugAllo Pro Corp. · 1990
  • K896669Weber PermalockAllo Pro Corp. · 1990
  • K892644Biolox Ceramic BallAllo Pro Corp. · 1989

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/K830949 · printed Nov 6, 2026

Cite this page

510(k) Report. “K830949: Polyethylene Medullary Plug - Stiihmer/.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830949

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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