# K061824: Tornier Cement Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Sep 14, 2006 after 78 days
- Product code: LZN (Cement Obturator)
- 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 K830949 (1983). 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)
- K973453: Tornier Cement Restrictor, Tornier (1997) Summary page 1.
- K001932: Tornier Cement Restrictor, Tornier (2000)
- K830949: Polyethylene Medullary Plug - Stiihmer/, Allo Pro Corp. (1983) Summary page 1.
- K001733: Allen Medullary Cement Plugs, Zimmer Poly Plug Intramedullary System, Model 8011 Series & 1109 & 8109 Series, Zimmer, Inc. (2000) Summary page 1.

## Indications for use
The Tornier Cement restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during joint arthroplasty. The Tornier Cement restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation when the implant is introduced.

Source page: https://510kreport.com/device/K061824
Methodology: https://510kreport.com/methodology