# K023680: Biobuck Cement Restrictor

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 19, 2002 after 18 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: 2 generations back to K000587 (2000). 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)
- K791125: Plug-Lok Cement Restirctor, Richard'S Medical Equip., Inc. (1979) Summary page 1.
- K000587: Shuttle Stop, Isotis NV (2000) Summary page 1.
- K010840: Synplug, Isotis NV (2001)

## Indications for use
The BioBuck Cement Restrictor is a bullet-shaped plug with stabilizing and sealing rings intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.

Source page: https://510kreport.com/device/K023680
Methodology: https://510kreport.com/methodology