# K060132: Spinal Usa Cement Restrictor System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal USA
- Decided: Mar 16, 2006 after 57 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: 5 generations back to K003718 (2001). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052367: Scient'x Cement Restrictor, Scient'X (2005) Summary page 1.
- K040276: Quantum Cement Restrictor, Quantum Orthopedics (2004) Summary page 1.
- K021719: Fortitude Cement Restrictor, Spinal Concepts, Inc. (2002) Summary page 1.

## Indications for use
The Spinal USA Cement Restrictor System 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 thait device when implanted in the spine have not been established.

Source page: https://510kreport.com/device/K060132
Methodology: https://510kreport.com/methodology