# K042465: PS Medical Strata II Valve

- Pathway: 510(k) (Special)
- Applicant: Medtronic Neurosurgery
- Decided: Oct 19, 2004 after 36 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 4 (0 Class I)
- 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.
19 later devices descend from it; 6 cite it directly.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012052: Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855, Medtronic PS Medical (2002)
- K040943: Medtronic PS Medical Strata Valve, Medtronic Neurosurgery (2004) Summary page 1.
- K033850: Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without Bioglide, Medtronic Neurosurgery (2004) Summary page 1.

## Most influential descendants
- K060681: Medtronic PS Medical Strata Type Value (2006), 7 descendants of its own
- K062009: Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451T (2007), 6 descendants of its own
- K103003: Aesculap- Meithke Progav Programmable Shunt System (2010), 4 descendants of its own
- K110206: Aesculap- Meithke Shunt System (2011), 3 descendants of its own
- K112156: Codman Certas Programmable Valve System, Codman Certas Therapy Management System (2011), 3 descendants of its own

## Recalls of this device
- Jan 11, 2021 · Class II · Z-1115-2021: Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
- 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
- Jan 17, 2017 · Class II · Z-1121-2017: Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressure/performance level (
- Nov 18, 2013 · Class II · Z-0399-2014: Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

## Indications for use
The Medtronic PS Medical Strata II Valve and shunt assemblies with and without BioGlide are shunt components designed to provide continued CSF flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using a special magnetic adjustment tool without the need for radiographic confirmation.

Source page: https://510kreport.com/device/K042465
Methodology: https://510kreport.com/methodology