# K913636: Orbis-Sigma Valve System for Ventricular Shunting

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Dec 12, 1991 after 119 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K971799: Precision Flow Osv II (1998), 5 descendants of its own
- K042192: Low Flow Osv II Hydrocephalus Valve (2004), 3 descendants of its own
- K081773: OSV II (2008), 2 descendants of its own
- K093968: Osv II Low Flow Low Pro Valve (2010), 1 descendant of its own
- K092395: Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve System (2009), 1 descendant of its own

Source page: https://510kreport.com/device/K913636
Methodology: https://510kreport.com/methodology