# K021719: Fortitude Cement Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Concepts, Inc.
- Decided: Aug 15, 2002 after 84 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: 2 generations back to K900138 (1990). 6 ancestors in all.
6 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)
- K012255: Medtronic Sofamor Danek Cement Restrictor, Medtronic Sofamor Danek, Inc. (2001)
- K013014: Block Cement Restrictor (CR) - Titanium, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.
- K990345: Rabea Device, Model Pxxxxxx, Signus Medizintechnik GmbH (1999) Summary page 1.

## Most influential descendants
- K031837: Modification to Fortitude Cement Restrictor (2003), 5 descendants of its own
- 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

## Indications for use
The Fortitude Cement Restrictor System 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 use in spinal applications.

Source page: https://510kreport.com/device/K021719
Methodology: https://510kreport.com/methodology