# K011998: Metronic Sofamor Danek Cement Restrictor

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Jul 26, 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## 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/K011998
Methodology: https://510kreport.com/methodology