510(k) · Decided
DecidedFidji Small Cement Restrictor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Next SA · JDK Prosthesis, Hip, Cement Restrictor
Cleared on Dec 22, 2003 as substantially equivalent to K013663 (Medtronic Sofamor Danek, Inc., 2001) after a 286-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Dec 22, 2003
- Review
- 286 days
- Class
- Class II
- Product code
- JDK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003718 (2001). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK003718 Titanium Cement Restrictor (TCR)Medtronic Sofamor Danek, Inc. · 2001
- 2 generations backK013014 Block Cement Restrictor (CR) - TitaniumMedtronic Sofamor Danek, Inc. · 2001
- 1 generation backK013663 Cement RestrictorMedtronic Sofamor Danek, Inc. · 2001
- This deviceK030767 Fidji Small Cement RestrictorSpine Next SA · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003718 | Titanium Cement Restrictor (TCR) | Medtronic Sofamor Danek, Inc. | 2001 | — |
| −2 | K013014 | Block Cement Restrictor (CR) - Titanium | Medtronic Sofamor Danek, Inc. | 2001 | — |
| −1 | K013663 | Cement Restrictor | Medtronic Sofamor Danek, Inc. | 2001 | — |
| 0 (this device) | K030767 | Fidji Small Cement Restrictor | Spine Next SA | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K013663 | Cement RestrictorSummary page 1…rietary Name: Fidji Small Cement Restrictor PREDICATE DEVICE Cement Restrictor (CR) manufactured by Medtronic Sofamor Danek USA, Inc. [reference 5 10(k) K01 3663 cleared December 5, 200 11 This summary of 5 10(k) safety and effectiveness information is being submitted in accordance wit… | 2001 |
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 2 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K013663.
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 Fidji Small Cement Restrictor is intended for use in conjunction with standard PMMA cement and is designed to occlude the medullary canal during the introduction of the cement during surgeries such as arthroplasty. It is also designed to prevent cement from flowing down the diaphysis thereby facilitating cement pressurization.
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/K030767 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030767: Fidji Small 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/K030767
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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