# K021788: NBD Cement Restrictor Device

- Pathway: 510(k) (Traditional)
- Applicant: New Business Development, LLC
- Decided: Oct 4, 2002 after 126 days
- Product code: JDK (Prosthesis, Hip, Cement Restrictor)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K900138 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990345: Rabea Device, Model Pxxxxxx, Signus Medizintechnik GmbH (1999) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K021788
Methodology: https://510kreport.com/methodology