# K012255: Medtronic Sofamor Danek Cement Restrictor

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Aug 1, 2001 after 14 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 K003718 (2001). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003718: Titanium Cement Restrictor (TCR), Medtronic Sofamor Danek, Inc. (2001) Summary page 1.

## Most influential descendants
- K021719: Fortitude Cement Restrictor (2002), 6 descendants of its own
- 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

## Indications for use
The Medtronic Sofamor Danek 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. The Medtronic Sofamor Danek Cement Restrictor is NOT intended for any spinal indications.

Source page: https://510kreport.com/device/K012255
Methodology: https://510kreport.com/methodology