# K123524: Medtronic Strata NSC Lumboperitoneal Valve and Shunt System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Neurosurgery
- Decided: Feb 13, 2013 after 90 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K944222 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091312: PS Medical Strata NSC Lumboperitoneal Valve and Shunt System, Medtronic Neurosurgery (2009) Summary page 1.
- K831396: P-S Medical CSF-Lumboperitoneal Shunt, Pudenz-Schulte Medical Research Corp. (1983) Summary page 1.

## Recalls of this device
- Jan 11, 2021 · Class II · Z-1116-2021: Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

## 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 in order to address changing patient needs. The Strata NSC Lumboperitoneal Shunt System is designed for management of communicating hydrocephalus and may be used in the treatment of idiopathic intracranial hypertension (pseudlotumor cerebri) when shunting is an option.

Source page: https://510kreport.com/device/K123524
Methodology: https://510kreport.com/methodology