# K013663: Cement Restrictor

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Dec 5, 2001 after 29 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 K003718 (2001). 3 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013014: Block Cement Restrictor (CR) - Titanium, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.
- K010528: Titanium Cement Restrictor Material Peek, Medtronic Sofamor Danek USA, Inc. (2001) Summary page 1.

## Most influential descendants
- K020836: Rabea Cement Restrictor (2002), 4 descendants of its own
- K052367: Scient'x Cement Restrictor (2005), 1 descendant of its own
- K022729: Vented Cement Restrictor (2002), 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 CEMENT RESTRICTOR (CR) is intended for use as a cement restrictor in orthopedic surgeries in the femur and tibia in hip and knee replacement. The CEMENT RESTRICTOR (CR) is NOT intended for any spinal indications.

Source page: https://510kreport.com/device/K013663
Methodology: https://510kreport.com/methodology