510(k) · Cleared
ClearedSpinal Usa Cement Restrictor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal USA · JDK Prosthesis, Hip, Cement Restrictor
Cleared on Mar 16, 2006 as substantially equivalent to K052367 (Scient'X, 2005) and 2 other predicates after a 57-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Mar 16, 2006
- Review
- 57 days
- Class
- Class II
- Product code
- JDK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K003718 (2001). 13 ancestors in all, the oldest K900138 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK003718 Titanium Cement Restrictor (TCR)Medtronic Sofamor Danek, Inc. · 2001
- 4 generations backK013014 Block Cement Restrictor (CR) - TitaniumMedtronic Sofamor Danek, Inc. · 2001
- 3 generations backK013663 Cement RestrictorMedtronic Sofamor Danek, Inc. · 2001
- 2 generations backK020836 Rabea Cement RestrictorSignus Medical, LLC · 2002
- 1 generation backK052367 Scient'x Cement RestrictorScient'X · 2005
- This deviceK060132 Spinal Usa Cement Restrictor SystemSpinal USA · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003718 | Titanium Cement Restrictor (TCR) | Medtronic Sofamor Danek, Inc. | 2001 | — |
| −4 | K013014 | Block Cement Restrictor (CR) - Titanium | Medtronic Sofamor Danek, Inc. | 2001 | — |
| −3 | K013663 | Cement Restrictor | Medtronic Sofamor Danek, Inc. | 2001 | — |
| −2 | K020836 | Rabea Cement Restrictor | Signus Medical, LLC | 2002 | — |
| −1 | K052367 | Scient'x Cement Restrictor | Scient'X | 2005 | — |
| 0 (this device) | 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 |
| 2004 | 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? (3)
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 |
|---|---|---|---|
| * | K052367 | Scient'x Cement RestrictorSummary page 1…ALENT DEVICE: The Spinal USA Cement Restrictor System was demonstrated to be substantially equivalent to previous cleared devices such as the Scient'X Cement Restrictor (K052367), Quantum Cement Restrictor (K040276), and Fortitude Cement Restrictor (K02 1719). The subject device and predicate devices have… | 2005 |
| * | K040276 | Quantum Cement RestrictorSummary page 1…estrictor System was demonstrated to be substantially equivalent to previous cleared devices such as the Scient'X Cement Restrictor (K052367), Quantum Cement Restrictor (K040276), and Fortitude Cement Restrictor (K02 1719). The subject device and predicate devices have the following similarities: -the same… | 2004 |
| * | K021719 | Fortitude Cement RestrictorSummary page 1…stantially equivalent to previous cleared devices such as the Scient'X Cement Restrictor (K052367), Quantum Cement Restrictor (K040276), and Fortitude Cement Restrictor (K02 1719). The subject device and predicate devices have the following similarities: -the same indication for use -the same operating prin… | 2002 |
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?
- The line of descent spans 5 years and passes through 4 companies; a new generation was cleared every 6 months on median.
- None of the 13 ancestors has a recall.
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 Spinal USA Cement Restrictor System 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 thait device when implanted in the spine have not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060132: Spinal Usa Cement Restrictor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060132
Report an extraction error
Are you the manufacturer?
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