510(k) · Cleared
ClearedPlug-Lok Cement Restirctor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard'S Medical Equip., Inc. · LZN Cement Obturator
Cleared on Jun 27, 1979 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.
- Decided
- Jun 27, 1979
- Review
- 9 days
- Class
- Class II
- Product code
- LZN
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 5 citing it directly.
- This deviceK791125 Plug-Lok Cement RestirctorRichard'S Medical Equip., Inc. · 1979
- Descendant · cites it directly · 7 of its ownK152084 Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with…Corentec Co., Ltd. · 2016 · Recalled
- Descendant · 2 generations on · 6 of its ownK162127 Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · Recalled
- Descendant · cites it directly · 5 of its ownK133370 Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve…Signature Orthopaedics Pty Limited · 2014
- Descendant · 3 generations on · 4 of its ownK172806 Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd. · 2016 · cites it directly7descendants
- K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · 2 generations on6descendants
- K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited · 2014 · cites it directly5descendants
- K172806Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017 · 3 generations on4descendants
- K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K791125 | Plug-Lok Cement Restirctor | Richard'S Medical Equip., Inc. | 1979 | — |
| +1 | K152084 | Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with… | Corentec Co., Ltd. | 2016 | 1 |
| +2 | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | 2016 | 1 |
| +1 | K133370 | Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip… | Signature Orthopaedics Pty Limited | 2014 | — |
| +3 | K172806 | Bencox Mirabo Cup System | Corentec Co., Ltd. | 2017 | — |
| +1 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
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 K220838 Artisan Bone Plug, Universal Cement Restrictorscore 11.8 · 9 generations · no Class I recall
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? (20)
See all 205 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152084 | Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &… | 2016 | 7 |
| K133370 | Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem… | 2014 | 5 |
| K211176 | Smith & Nephew Hip Systems | 2022 | 3 |
| K210062 | Mectaplug PE II | 2021 | 0 |
| K023680 | Biobuck Cement Restrictor | 2002 | 0 |
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, K152084 (Corentec Co., Ltd., 2016) has gone furthest, with 7 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 | — |
https://510kreport.com/device/K791125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K791125: Plug-Lok Cement Restirctor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K791125
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026