# K020836: Rabea Cement Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medical, LLC
- Decided: Jun 11, 2002 after 89 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: 3 generations back to K003718 (2001). 7 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 12 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 1.
- K013663: Cement Restrictor, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.

## Most influential descendants
- K052367: Scient'x Cement Restrictor (2005), 1 descendant of its own
- K060132: Spinal Usa Cement Restrictor System (2006), 0 descendants of its own
- K051371: Interbody Innovations Cement Restrictor (2005), 0 descendants of its own
- K033953: Optimesh 500E Cement Restrictor (2004), 0 descendants of its own

## Indications for use
The RABEA™ Cement Restrictor is intended to be used in orthopedic surgeries, such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries, nor is it intended for any spinal indications.

Source page: https://510kreport.com/device/K020836
Methodology: https://510kreport.com/methodology