# K112156: Codman Certas Programmable Valve System, Codman Certas Therapy Management System

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Oct 17, 2011 after 82 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: 7 generations back to K944222 (1995). 14 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974739: Hakim Programmable Valve System, Johnson & Johnson Professionals, Inc. (1998) Summary page 1.
- K060681: Medtronic PS Medical Strata Type Value, Medtronic Neurosurgery (2006) Summary page 1.
- K040943: Medtronic PS Medical Strata Valve, Medtronic Neurosurgery (2004) Summary page 1.
- K090342: Polaris Pressure Adjustable Valve, Models SPV, Spva, SPVB, SPV-140, SPV-300, SPV-400, Sophysa SA (2009) Summary page 1.

## Most influential descendants
- K143111: Codman Certas Plus Programmable Valve; Codman Certas Toll Kit (2015), 1 descendant of its own
- K181902: Codman Certas Plus Electronic Tool Kit (2018), 0 descendants of its own
- K113526: Codman Certas Programmable Valve System (2012), 0 descendants of its own

## 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 setting.

Source page: https://510kreport.com/device/K112156
Methodology: https://510kreport.com/methodology