510(k) · Decided
DecidedNBD Cement Restrictor Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Business Development, LLC · JDK Prosthesis, Hip, Cement Restrictor
Cleared on Oct 4, 2002 as substantially equivalent to K990345 (Signus Medizintechnik GmbH, 1999) after a 126-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Oct 4, 2002
- Review
- 126 days
- Class
- Class II
- Product code
- JDK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K900138 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
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) | K021788 | NBD Cement Restrictor Device | New Business Development, LLC | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 |
|---|---|---|---|
| * | K990345 | Rabea Device, Model PxxxxxxSummary page 2…Substantial Equivalence: The NBD Cement Restrictor Device is substantially equivalent to RA- BEATMCement Restrictor Device which was cleared for premarket noti- fication K990345 on July 30, 1999. The NBD Cement Restrictor is equivalent in design, function, material, and indications for use. Osteonics PTII… | 1999 |
| † | K914406 | PT II Distal Cement Spacer | 1991 |
| † | K900138 | Motech Titanium Surgical Mesh | 1990 |
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 12 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K990345.
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 NBD Cement Restrictor Device 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 NBD Cement Restrictor is NOT intended for any spinal indications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021788 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021788: NBD Cement Restrictor Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021788
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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