# K012462: Theken Large Cement Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Theken Surgical,Llc
- Decided: Oct 29, 2001 after 89 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K003718: Titanium Cement Restrictor (TCR), Medtronic Sofamor Danek, Inc. (2001) Summary page 1.

## Indications for use
The Theken Large Cement Restrictor is designed to occlude the medullary canal before the introduction of acrylic cement during surgeries such as total hip arthroplasty, as well as prevent cement from flowing down the diaphysis thereby facilitating cement pressurization. The Theken Large Cement Restrictor is NOT intended for any spinal indications.

Source page: https://510kreport.com/device/K012462
Methodology: https://510kreport.com/methodology