# K052367: Scient'x Cement Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Scient'X
- Decided: Oct 5, 2005 after 37 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: 4 generations back to K003718 (2001). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020836: Rabea Cement Restrictor, Signus Medical, LLC (2002) Summary page 1.
- K031837: Modification to Fortitude Cement Restrictor, Spinal Concepts, Inc. (2003) Summary page 1.

## Most influential descendants
- K060132: Spinal Usa Cement Restrictor System (2006), 0 descendants of its own

## Indications for use
The Scient'x Cement Restrictor is intended as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. 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.

Source page: https://510kreport.com/device/K052367
Methodology: https://510kreport.com/methodology