# K010840: Synplug

- Pathway: 510(k) (Special)
- Applicant: Isotis NV
- Decided: Apr 20, 2001 after 30 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 K000587 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000587: Shuttle Stop, Isotis NV (2000)

## Most influential descendants
- K023680: Biobuck Cement Restrictor (2002), 0 descendants of its own

## Indications for use
SynPlug' is a cylindrical plug intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.

Source page: https://510kreport.com/device/K010840
Methodology: https://510kreport.com/methodology