510(k) · Cleared
ClearedTornier Cement Restrictor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier · LZN Cement Obturator
Cleared on Sep 14, 2006 as substantially equivalent to K973453 (Tornier, 1997) and 3 other predicates after a 78-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Sep 14, 2006
- Review
- 78 days
- Class
- Class II
- Product code
- LZN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K830949 (1983). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK830949 Polyethylene Medullary Plug - Stiihmer/Allo Pro Corp. · 1983
- This deviceK061824 Tornier Cement RestrictorTornier · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830949 | Polyethylene Medullary Plug - Stiihmer/ | Allo Pro Corp. | 1983 | — |
| 0 (this device) | K061824 | Tornier Cement Restrictor | Tornier | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K973453 | Tornier Cement RestrictorSummary page 1…s: Class II Classification panel: Orthopedic Product code: UZN 5) Equivalent I Predicate device Tornier Cement Restrictor, TORNIER, K973453, KOO 1932 Alto Pro Cement Obturator, ALLO PRO, GmbH, K830949 Allen Medullary Cement Plug, ZIMMER., Ine, K001733 6) Device descri… | 1997 |
| * | K001932 | Tornier Cement Restrictor | 2000 |
| * | K830949 | Polyethylene Medullary Plug - Stiihmer/Summary page 1…pedic Product code: UZN 5) Equivalent I Predicate device Tornier Cement Restrictor, TORNIER, K973453, KOO 1932 Alto Pro Cement Obturator, ALLO PRO, GmbH, K830949 Allen Medullary Cement Plug, ZIMMER., Ine, K001733 6) Device description The Tornier Cement Restrictor is a diaphyseal plug for… | 1983 |
| * | K001733 | Allen Medullary Cement Plugs, Zimmer Poly Plug Intramedullary System, Model 8011 Series…Summary page 1…nt I Predicate device Tornier Cement Restrictor, TORNIER, K973453, KOO 1932 Alto Pro Cement Obturator, ALLO PRO, GmbH, K830949 Allen Medullary Cement Plug, ZIMMER., Ine, K001733 6) Device description The Tornier Cement Restrictor is a diaphyseal plug for orthopedic use. It is designed to occlude the medul… | 2000 |
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?
- 1 of the 4 ancestors has a recall of any class.
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 Tornier Cement restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during joint arthroplasty. The Tornier Cement restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation when the implant is introduced.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061824 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061824: Tornier Cement Restrictor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061824
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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