510(k) · Decided
DecidedFortitude Cement Restrictor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Concepts, Inc. · JDK Prosthesis, Hip, Cement Restrictor
Cleared on Aug 15, 2002 as substantially equivalent to K012255 (Medtronic Sofamor Danek, Inc., 2001) and 2 other predicates after an 84-day review. Its family tree reaches back 2 generations to 1990. 6 later devices descend from it.
- Decided
- Aug 15, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- JDK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K900138 (1990). 6 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK900138 Motech Titanium Surgical MeshBiedermann Motech GmbH · 1990
- 1 generation backK990345 Rabea Device, Model PxxxxxxSignus Medizintechnik GmbH · 1999
- This deviceK021719 Fortitude Cement RestrictorSpinal Concepts, Inc. · 2002
- Descendant · cites it directly · 5 of its ownK031837 Modification to Fortitude Cement RestrictorSpinal Concepts, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK052367 Scient'x Cement RestrictorScient'X · 2005
- Descendant · cites it directly · 0 of its ownK060132 Spinal Usa Cement Restrictor SystemSpinal USA · 2006
- Descendant · 2 generations on · 0 of its ownK051371 Interbody Innovations Cement RestrictorInterbody Innovations, Llp · 2005
- Descendant · cites it directly · 0 of its ownK051607 Novaspine Cement Restrictor NSCRNovaspine, LLC · 2005
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K031837Modification to Fortitude Cement RestrictorSpinal Concepts, Inc. · 2003 · cites it directly5descendants
- K052367Scient'x Cement RestrictorScient'X · 2005 · 2 generations on1descendant
- K060132Spinal Usa Cement Restrictor SystemSpinal USA · 2006 · cites it directly0descendants
- K051371Interbody Innovations Cement RestrictorInterbody Innovations, Llp · 2005 · 2 generations on0descendants
- K051607Novaspine Cement Restrictor NSCRNovaspine, LLC · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900138 | Motech Titanium Surgical Mesh | Biedermann Motech GmbH | 1990 | — |
| −1 | K990345 | Rabea Device, Model Pxxxxxx | Signus Medizintechnik GmbH | 1999 | — |
| 0 (this device) | K021719 | Fortitude Cement Restrictor | Spinal Concepts, Inc. | 2002 | — |
| +1 | K031837 | Modification to Fortitude Cement Restrictor | Spinal Concepts, Inc. | 2003 | — |
| +2 | K052367 | Scient'x Cement Restrictor | Scient'X | 2005 | — |
| +1 | K060132 | Spinal Usa Cement Restrictor System | Spinal USA | 2006 | — |
| +2 | K051371 | Interbody Innovations Cement Restrictor | Interbody Innovations, Llp | 2005 | — |
| +1 | K051607 | Novaspine Cement Restrictor NSCR | Novaspine, LLC | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K012255 | Medtronic Sofamor Danek Cement Restrictor | 2001 |
| * | K013014 | Block Cement Restrictor (CR) - TitaniumSummary page 1…ude Cement Restrictor was demonstrated to be substantially equivalent to previously cleared devices such as the Medtronic Sofamor Danek Cement Restrictor(s) (KO12255 and K013014) and the Signus RABEATMCement Restrictor (K990345). A Design Review for the device was provided in this submission.… | 2001 |
| * | K990345 | Rabea Device, Model PxxxxxxSummary page 1…gical characteristics to the predicate devices reviewed, the Medtronic Sofamor Danek Cement Restrictor(s) (KO12255 and KO1 3014) and the Signus RAREATMCement Restrictor (K990345). Device Description: The Fortitude Cement Restrictor is a hollow, titanium alloy device with teeth on two opposing flat sides.… | 1999 |
What descends from it? (6)
4 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K031837 (Spinal Concepts, Inc., 2003) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K012255.
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 Fortitude Cement Restrictor System 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.
This device is not intended for use in spinal applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021719 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021719: Fortitude Cement Restrictor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021719
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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