510(k) · Decided
DecidedMedtronic Sofamor Danek Cement Restrictor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · JDK Prosthesis, Hip, Cement Restrictor
Cleared on Aug 1, 2001 as substantially equivalent to K003718 (Medtronic Sofamor Danek, Inc., 2001) after a 14-day review. Its family tree reaches back 1 generation to 2001. 7 later devices descend from it.
- Decided
- Aug 1, 2001
- Review
- 14 days
- Class
- Class II
- Product code
- JDK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003718 (2001). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK003718 Titanium Cement Restrictor (TCR)Medtronic Sofamor Danek, Inc. · 2001
- This deviceK012255 Medtronic Sofamor Danek Cement RestrictorMedtronic Sofamor Danek, Inc. · 2001
- Descendant · cites it directly · 6 of its ownK021719 Fortitude Cement RestrictorSpinal Concepts, Inc. · 2002
- Descendant · 2 generations on · 5 of its ownK031837 Modification to Fortitude Cement RestrictorSpinal Concepts, Inc. · 2003
- Descendant · 3 generations on · 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 · 3 generations on · 0 of its ownK051371 Interbody Innovations Cement RestrictorInterbody Innovations, Llp · 2005
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K021719Fortitude Cement RestrictorSpinal Concepts, Inc. · 2002 · cites it directly6descendants
- K031837Modification to Fortitude Cement RestrictorSpinal Concepts, Inc. · 2003 · 2 generations on5descendants
- K052367Scient'x Cement RestrictorScient'X · 2005 · 3 generations on1descendant
- K060132Spinal Usa Cement Restrictor SystemSpinal USA · 2006 · 2 generations on0descendants
- K051371Interbody Innovations Cement RestrictorInterbody Innovations, Llp · 2005 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003718 | Titanium Cement Restrictor (TCR) | Medtronic Sofamor Danek, Inc. | 2001 | — |
| 0 (this device) | K012255 | Medtronic Sofamor Danek Cement Restrictor | Medtronic Sofamor Danek, Inc. | 2001 | — |
| +1 | K021719 | Fortitude Cement Restrictor | Spinal Concepts, Inc. | 2002 | — |
| +2 | K031837 | Modification to Fortitude Cement Restrictor | Spinal Concepts, Inc. | 2003 | — |
| +3 | K052367 | Scient'x Cement Restrictor | Scient'X | 2005 | — |
| +2 | K060132 | Spinal Usa Cement Restrictor System | Spinal USA | 2006 | — |
| +3 | K051371 | Interbody Innovations Cement Restrictor | Interbody Innovations, Llp | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K003718 | Titanium Cement Restrictor (TCR)Summary page 1…ence: The THREADED BULLET CEMENT RESTRICTOR was demonstrated to be substantially equivalent to the previously cleared device, Medtronic Sofamor Danek CEMENT RESTRICTOR (K003718). A Design Review for the modified device was provided in this submission. SERYICEs, w G, C DEPARTMENT OF HEALTH… | 2001 |
What descends from it? (7)
2 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 Medtronic Sofamor Danek Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
The Medtronic Sofamor Danek Cement Restrictor is NOT 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/K012255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012255: Medtronic Sofamor Danek 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/K012255
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026