510(k) · Cleared
ClearedRabea Cement Restrictor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signus Medical, LLC · JDK Prosthesis, Hip, Cement Restrictor
Cleared on Jun 11, 2002 as substantially equivalent to K990345 (Signus Medizintechnik GmbH, 1999) and 1 other predicate after an 89-day review. Its family tree reaches back 3 generations to 2001. 4 later devices descend from it.
- Decided
- Jun 11, 2002
- Review
- 89 days
- Class
- Class II
- Product code
- JDK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003718 (2001). 7 ancestors in all, the oldest K900138 (1990). 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK003718 Titanium Cement Restrictor (TCR)Medtronic Sofamor Danek, Inc. · 2001
- 2 generations backK013014 Block Cement Restrictor (CR) - TitaniumMedtronic Sofamor Danek, Inc. · 2001
- 1 generation backK013663 Cement RestrictorMedtronic Sofamor Danek, Inc. · 2001
- This deviceK020836 Rabea Cement RestrictorSignus Medical, LLC · 2002
- Descendant · cites it directly · 1 of its ownK052367 Scient'x Cement RestrictorScient'X · 2005
- Descendant · 2 generations on · 0 of its ownK060132 Spinal Usa Cement Restrictor SystemSpinal USA · 2006
- Descendant · cites it directly · 0 of its ownK051371 Interbody Innovations Cement RestrictorInterbody Innovations, Llp · 2005
- Descendant · cites it directly · 0 of its ownK033953 Optimesh 500E Cement RestrictorSpineology, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K052367Scient'x Cement RestrictorScient'X · 2005 · cites it directly1descendant
- K060132Spinal Usa Cement Restrictor SystemSpinal USA · 2006 · 2 generations on0descendants
- K051371Interbody Innovations Cement RestrictorInterbody Innovations, Llp · 2005 · cites it directly0descendants
- K033953Optimesh 500E Cement RestrictorSpineology, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003718 | Titanium Cement Restrictor (TCR) | Medtronic Sofamor Danek, Inc. | 2001 | — |
| −2 | K013014 | Block Cement Restrictor (CR) - Titanium | Medtronic Sofamor Danek, Inc. | 2001 | — |
| −1 | K013663 | Cement Restrictor | Medtronic Sofamor Danek, Inc. | 2001 | — |
| 0 (this device) | K020836 | Rabea Cement Restrictor | Signus Medical, LLC | 2002 | — |
| +1 | K052367 | Scient'x Cement Restrictor | Scient'X | 2005 | — |
| +2 | K060132 | Spinal Usa Cement Restrictor System | Spinal USA | 2006 | — |
| +1 | K051371 | Interbody Innovations Cement Restrictor | Interbody Innovations, Llp | 2005 | — |
| +1 | K033953 | Optimesh 500E Cement Restrictor | Spineology, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 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 JDK? 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 JDK device
- #1 K210062 Mectaplug PE IIscore 5.0 · 14 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990345 | Rabea Device, Model PxxxxxxSummary page 1…™ (Cement Restrictor Cement Restrictor Class {1, 21 CFR &7&.3300 JDK The RABEA™ Cement Restrictor is substantially equivalent to: e RABEA™ Titanium Cemeut Restrictor (K990345) » Medtronic Sofamor Danek Cement Restrictar (K013663) The RABEA™ Cement Restrictor is a hollow, PEEK rounded rectangular frame… | 1999 |
| * | K013663 | Cement RestrictorSummary page 1…CFR &7&.3300 JDK The RABEA™ Cement Restrictor is substantially equivalent to: e RABEA™ Titanium Cemeut Restrictor (K990345) » Medtronic Sofamor Danek Cement Restrictar (K013663) The RABEA™ Cement Restrictor is a hollow, PEEK rounded rectangular frame with fenestrated surfaces on all sides and lmm toothed… | 2001 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All JDK devicesJDK Prosthesis, Hip, Cement Restrictor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDK
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JDK
Too few JDK 510(k)s in any year since 2007 to give a median.
Recalls per year · JDK
5in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDK
6in 2025
MAUDE reports naming product code JDK, 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 | — | 6 | 3 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 5 | 3 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RABEA™ Cement Restrictor is intended to be used in orthopedic surgeries, such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries, nor is it intended for any spinal indications.
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/K020836 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020836: Rabea Cement Restrictor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020836
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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