# K060681: Medtronic PS Medical Strata Type Value

- Pathway: 510(k) (Special)
- Applicant: Medtronic Neurosurgery
- Decided: Sep 15, 2006 after 184 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 2 (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.
7 later devices descend from it; 2 cite it directly.
1 of 20 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) Summary page 1.
- K033850: Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without Bioglide, Medtronic Neurosurgery (2004) Summary page 1.
- K040943: Medtronic PS Medical Strata Valve, Medtronic Neurosurgery (2004) Summary page 1.
- K042465: PS Medical Strata II Valve, Medtronic Neurosurgery (2004) Summary page 1.

## Most influential descendants
- K112156: Codman Certas Programmable Valve System, Codman Certas Therapy Management System (2011), 3 descendants of its own
- K152700: StrataMR Valves and Shunts (2016), 2 descendants of its own
- K143111: Codman Certas Plus Programmable Valve; Codman Certas Toll Kit (2015), 1 descendant of its own
- K212641: StrataMR II Valves and Shunts (2021), 0 descendants of its own
- K181902: Codman Certas Plus Electronic Tool Kit (2018), 0 descendants of its own

## 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
- 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 (

## Indications for use
The Medtronic PS Medical® Strata® Valve and Strata® NSC Valve are shunt components designed to provide continued Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using an external magnetic adjustment tool without the need for radiographic confirmation. The Medtronic PS Medical® Strata® IIValve 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/K060681
Methodology: https://510kreport.com/methodology