# K091312: PS Medical Strata NSC Lumboperitoneal Valve and Shunt System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Neurosurgery
- Decided: Sep 2, 2009 after 121 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
Longest line of descent: 5 generations back to K944222 (1995). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033850: Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without Bioglide, Medtronic Neurosurgery (2004) Summary page 1.
- K831396: P-S Medical CSF-Lumboperitoneal Shunt, Pudenz-Schulte Medical Research Corp. (1983) Summary page 1.

## Most influential descendants
- K123524: Medtronic Strata NSC Lumboperitoneal Valve and Shunt System (2013), 0 descendants of its own

## Indications for use
The Strata NSC Lumboperitoneal Shunt System provides continued cerebrospinal fluid (CSF) flow from the subarachnoid space into the peritoneal cavity. The Strata NSC Lumboperitoneal Valve allows the physician to non-invasively adjust the pressure/flow performance level pre- and post-implantation without the need for radiographic confirmation in order to address changing patient needs. The Strata NSC Lumboperitoneal Shunt System is designed for management of communicating hydrocephalus.

Source page: https://510kreport.com/device/K091312
Methodology: https://510kreport.com/methodology