# K990345: Rabea Device, Model Pxxxxxx

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medizintechnik GmbH
- Decided: Jul 30, 1999 after 176 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: 1 generation back to K900138 (1990). 2 ancestors in all.
46 later devices descend from it; 6 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914406: PT II Distal Cement Spacer, Osteonics Corp. (1991) Summary page 1.
- K900138: Motech Titanium Surgical Mesh, Biedermann Motech GmbH (1990) Summary page 1.

## Most influential descendants
- K020344: RPX Titanium Cemnt Restrictor (2002), 33 descendants of its own
- K022615: Centerpulse, Spine-Tech Division Cement Restrictor (2002), 32 descendants of its own
- K091425: Quantum M Composite Nailing System (2010), 31 descendants of its own
- K100497: Quantum IM Composite Nailing System (Quantum Nailing System) (2010), 29 descendants of its own
- K102369: Piccolo Composite Nailing System (2011), 16 descendants of its own

## Indications for use
The RABEAT Cement Restrictor Device is intended for usc as a cement restrictor in orthopedic surgeries such as those involving the fernuial canal end tibial plateau in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgerics.

Source page: https://510kreport.com/device/K990345
Methodology: https://510kreport.com/methodology