# K120559: Aesculap-Meithke Prosa Adjustable Shunt System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: May 24, 2012 after 90 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: 8 generations back to K944222 (1995). 19 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062009: Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451T, Aesculap, Inc. (2007) Summary page 1.
- K103003: Aesculap- Meithke Progav Programmable Shunt System, Aesculap, Inc. (2010) Summary page 1.
- K011030: Aesculap -Miethke Shunt System, Aesculap, Inc. (2002) Summary page 1.
- K110206: Aesculap- Meithke Shunt System, Aesculap, Inc. (2011) Summary page 1.

## Most influential descendants
- K161853: proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System (2017), 1 descendant of its own
- K192266: M. Blue Adjustable Shunt System (2019), 0 descendants of its own

## Recalls of this device
- Dec 17, 2014 · Class II · Z-1012-2015: Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product i
- Dec 23, 2013 · Class II · Z-0989-2014: The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.

## Indications for use
The Miethke proSA Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. Adjustments of the proSA shunt can be verified by using the verification instrument but must be confirmed by radiograph (x-ray).

Source page: https://510kreport.com/device/K120559
Methodology: https://510kreport.com/methodology