# K032685: Cemstop Cement Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Teknimed, S.A.
- Decided: Nov 26, 2003 after 89 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 K943727 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943727: Biostop G Bone Cement Restrictor, Landos, Inc. (1995) Summary page 4.

## Cited in the summary but kept off the family tree
- K993841: Cemstop Cement Restrictor, Encore Orthopedics, Inc. (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The CEMSTOP Cement Restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty. The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurization.

Source page: https://510kreport.com/device/K032685
Methodology: https://510kreport.com/methodology