510(k) · Cleared
ClearedCadence 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 12, 2002 as substantially equivalent to K010528 (Medtronic Sofamor Danek USA, Inc., 2001) and 2 other predicates after a 34-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.
- Decided
- Aug 12, 2002
- Review
- 34 days
- Class
- Class II
- Product code
- JDK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K003718 (2001). 3 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK003718 Titanium Cement Restrictor (TCR)Medtronic Sofamor Danek, Inc. · 2001
- This deviceK022218 Cadence Cement RestrictorSpinal Concepts, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK023647 Cadence Peek Cemeent RestrictorSpinal Concepts, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK031318 Traxis Cement RestrictorSpinal Concepts, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK051607 Novaspine Cement Restrictor NSCRNovaspine, LLC · 2005
- Descendant · 2 generations on · 0 of its ownK041583 Peek Cement Restrictor X-BoxInnovasis, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K023647Cadence Peek Cemeent RestrictorSpinal Concepts, Inc. · 2002 · cites it directly2descendants
- K031318Traxis Cement RestrictorSpinal Concepts, Inc. · 2003 · cites it directly1descendant
- K051607Novaspine Cement Restrictor NSCRNovaspine, LLC · 2005 · cites it directly0descendants
- K041583Peek Cement Restrictor X-BoxInnovasis, Inc. · 2004 · 2 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) | K022218 | Cadence Cement Restrictor | Spinal Concepts, Inc. | 2002 | — |
| +1 | K023647 | Cadence Peek Cemeent Restrictor | Spinal Concepts, Inc. | 2002 | — |
| +1 | K031318 | Traxis Cement Restrictor | Spinal Concepts, Inc. | 2003 | — |
| +1 | K051607 | Novaspine Cement Restrictor NSCR | Novaspine, LLC | 2005 | — |
| +2 | K041583 | Peek Cement Restrictor X-Box | Innovasis, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K010528 | Titanium Cement Restrictor Material Peek | 2001 |
| * | K003718 | Titanium Cement Restrictor (TCR) | 2001 |
| * | K010529 | Titanium Cement Restrictor Material PldlaSummary page 1…ogical characteristics to the predicate devices reviewed, the Medtronic Sofamor Danek Cement Restrictor (KO10528) and its Medtronic Sofamor Danek predicates (KO03718 and K010529). Device Description: The CadenceTMCement Restrictor is a hollow device with teeth on two opposing flat sides. The device is cra… | 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022218: Cadence 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/K022218
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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