# K113526: Codman Certas Programmable Valve System

- Pathway: 510(k) (Special)
- Applicant: Medos International SARL
- Decided: Feb 16, 2012 after 78 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 16 (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). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112156: Codman Certas Programmable Valve System, Codman Certas Therapy Management System, Medos International SARL (2011) Summary page 1.

## Recalls of this device
- Jul 3, 2014 · Class II · Z-2184-2014: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- Jul 3, 2014 · Class II · Z-2189-2014: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- Jul 3, 2014 · Class II · Z-2191-2014: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- Jul 3, 2014 · Class II · Z-2190-2014: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- Jul 3, 2014 · Class II · Z-2188-2014: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- Jul 3, 2014 · Class II · Z-2185-2014: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- Jul 3, 2014 · Class II · Z-2187-2014: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- Jul 3, 2014 · Class II · Z-2186-2014: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- Dec 13, 2013 · Class II · Z-1468-2014: Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves.
- May 16, 2013 · Class II · Z-0858-2014: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
- May 16, 2013 · Class II · Z-0863-2014: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
- May 16, 2013 · Class II · Z-0860-2014: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
- May 16, 2013 · Class II · Z-0861-2014: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
- May 16, 2013 · Class II · Z-0862-2014: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
- May 16, 2013 · Class II · Z-0859-2014: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
- May 16, 2013 · Class II · Z-0864-2014: Codman Certas Programmable Valves used for hydrocephalus may not operate properly

## Indications for use
The CODMAN Certas Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. The CODMAN Certas Therapy Management System allows the noninvasive reading or adjustment of the valve selling.

Source page: https://510kreport.com/device/K113526
Methodology: https://510kreport.com/methodology