510(k) · Decided
DecidedScient'x Cement Restrictor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scient'X · JDK Prosthesis, Hip, Cement Restrictor
Cleared on Oct 5, 2005 as substantially equivalent to K020836 (Signus Medical, LLC, 2002) and 1 other predicate after a 37-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Oct 5, 2005
- Review
- 37 days
- Class
- Class II
- Product code
- JDK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K003718 (2001). 11 ancestors in all, the oldest K900138 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK003718 Titanium Cement Restrictor (TCR)Medtronic Sofamor Danek, Inc. · 2001
- 3 generations backK013014 Block Cement Restrictor (CR) - TitaniumMedtronic Sofamor Danek, Inc. · 2001
- 2 generations backK013663 Cement RestrictorMedtronic Sofamor Danek, Inc. · 2001
- 1 generation backK020836 Rabea Cement RestrictorSignus Medical, LLC · 2002
- This deviceK052367 Scient'x Cement RestrictorScient'X · 2005
- Descendant · cites it directly · 0 of its ownK060132 Spinal Usa Cement Restrictor SystemSpinal USA · 2006
Most influential descendants
Showing 1 of 1 · See all- K060132Spinal Usa Cement Restrictor SystemSpinal USA · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003718 | Titanium Cement Restrictor (TCR) | Medtronic Sofamor Danek, Inc. | 2001 | — |
| −3 | K013014 | Block Cement Restrictor (CR) - Titanium | Medtronic Sofamor Danek, Inc. | 2001 | — |
| −2 | K013663 | Cement Restrictor | Medtronic Sofamor Danek, Inc. | 2001 | — |
| −1 | K020836 | Rabea Cement Restrictor | Signus Medical, LLC | 2002 | — |
| 0 (this device) | K052367 | Scient'x Cement Restrictor | Scient'X | 2005 | — |
| +1 | K060132 | Spinal Usa Cement Restrictor System | Spinal USA | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K020836 | Rabea Cement RestrictorSummary page 1…ment restrictor Classification name Class 11 per 21 CER section 888.3300 Product Code JDK Equivalent Device RABEATINI Cement Restrictor (Signus Medical, K020836) FortitudeTM Cement Restrictor (Spinal Concepts, K03 1837) IDevicc Description The Scient'x Cement Restr… | 2002 |
| * | K031837 | Modification to Fortitude Cement RestrictorSummary page 1…duct Code JDK Equivalent Device RABEATINI Cement Restrictor (Signus Medical, K020836) FortitudeTM Cement Restrictor (Spinal Concepts, K03 1837) IDevicc Description The Scient'x Cement Restrietor is a hollow trapezoidal block with… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060132 | Spinal Usa Cement Restrictor System | 2006 | 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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K060132 (Spinal USA, 2006) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K020836.
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 Scient'x Cement Restrictor is intended as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
This device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052367: Scient'x 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/K052367
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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