510(k) · Cleared
ClearedCemstop Cement Restrictor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teknimed, S.A. · LZN Cement Obturator
Cleared on Nov 26, 2003 as substantially equivalent to K943727 (Landos, Inc., 1995) after an 89-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Nov 26, 2003
- Review
- 89 days
- Class
- Class II
- Product code
- LZN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K943727 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK943727 Biostop G Bone Cement RestrictorLandos, Inc. · 1995 · Recalled
- This deviceK032685 Cemstop Cement RestrictorTeknimed, S.A. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943727 | Biostop G Bone Cement Restrictor | Landos, Inc. | 1995 | 1 |
| 0 (this device) | K032685 | Cemstop Cement Restrictor | Teknimed, S.A. | 2003 | — |
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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K993841 | FDA’s K993841 is Cemstop Cement Restrictor Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2000 |
| * | K943727 | Biostop G Bone Cement RestrictorSummary page 4…t restrictor Classification name Cement obturator Equivalent Device Exactly the same as cleared on K99384! by Encore Medical. Equivalent to BIOSTOP (Landos) cleared on K943727. Device Description The CEMSTOP Cement Restrictor is inserted into the femoral canal prior to introduction of bone cement durin… | 1995 |
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?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K943727.
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 CEMSTOP Cement Restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty. The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurization.
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/K032685 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032685: Cemstop 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/K032685
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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