# K031837: Modification to Fortitude Cement Restrictor

- Pathway: 510(k) (Special)
- Applicant: Spinal Concepts, Inc.
- Decided: Jul 24, 2003 after 38 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 K900138 (1990). 7 ancestors in all.
5 later devices descend from it; 4 cite 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)
- K021719: Fortitude Cement Restrictor, Spinal Concepts, Inc. (2002)

## 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
- K051607: Novaspine Cement Restrictor NSCR (2005), 0 descendants of its own
- K041583: Peek Cement Restrictor X-Box (2004), 0 descendants of its own

## Indications for use
The Fortitude Cement Restrictor 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. 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/K031837
Methodology: https://510kreport.com/methodology