# K012278: Theken Small Cement Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Theken Surgical,Llc
- Decided: Oct 17, 2001 after 90 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990345: Rabea Device, Model Pxxxxxx, Signus Medizintechnik GmbH (1999) Summary page 1.

## Indications for use
The Theken Small Cement Restrictor is intended for use as a cement restrictor in orthopaedic surgeries such as those involving the tibial plateau in total knee replacement. The Theken Small Cement Restrictor is NOT intended for any spinal indications.

Source page: https://510kreport.com/device/K012278
Methodology: https://510kreport.com/methodology