510(k) · Cleared
Recalled · Class II · 2014Codman Certas Programmable Valve System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · JXG Shunt, Central Nervous System And Components
Cleared on Feb 16, 2012 as substantially equivalent to K112156 (Medos International SARL, 2011) after a 78-day review. Its family tree reaches back 8 generations to 1995. It has been recalled 16 times.
- Decided
- Feb 16, 2012
- Review
- 78 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 16
- Predicates
- 1
Its longest line of descent runs back 8 generations to K944222 (1995). 15 ancestors in all, the oldest K861377 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 7 generations backK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
- 6 generations backK980778 Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
- 5 generations backK012052 Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002
- 4 generations backK033850 Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and…Medtronic Neurosurgery · 2004 · Recalled
- 3 generations backK042465 PS Medical Strata II ValveMedtronic Neurosurgery · 2004 · Recalled
- 2 generations backK060681 Medtronic PS Medical Strata Type ValueMedtronic Neurosurgery · 2006 · Recalled
- 1 generation backK112156 Codman Certas Programmable Valve System, Codman Certas Therapy…Medos International SARL · 2011 · Recalled
- This deviceK113526 Codman Certas Programmable Valve SystemMedos International SARL · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K944222 | Codman-Medos Valve Shunt System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −7 | K973774 | Codman Hakim Micro Precision Valve | Johnson & Johnson Professionals, Inc. | 1997 | — |
| −6 | K980778 | Hakim Micro Programmable Valve System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −5 | K012052 | Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 | Medtronic PS Medical | 2002 | — |
| −4 | K033850 | Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without… | Medtronic Neurosurgery | 2004 | 2 |
| −3 | K042465 | PS Medical Strata II Valve | Medtronic Neurosurgery | 2004 | 4 |
| −2 | K060681 | Medtronic PS Medical Strata Type Value | Medtronic Neurosurgery | 2006 | 2 |
| −1 | K112156 | Codman Certas Programmable Valve System, Codman Certas Therapy Management System | Medos International SARL | 2011 | 16 |
| 0 (this device) | K113526 | Codman Certas Programmable Valve System | Medos International SARL | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JXG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JXG device
- #1 K243531 Codman Libertís Shunt Catheter with Bactiseal…score 11.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112156 | Codman Certas Programmable Valve System, Codman Certas Therapy Management SystemSummary page 1…tion: Class 1F(JXG) Central Nervous System Fluid Shunt and Components Legally Marketed Predicate Devices: K1 12156 - Certas Programmable Valve System Device Description: The Certas Programmable Valve System is designed f… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 3, 2014 | Class II | Z-2184-2014 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Process control | 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 | Device Design | Codman Certas Programmable Valves used for hydrocephalus may not operate properly |
| May 16, 2013 | Class II | Z-0863-2014 | Device Design | Codman Certas Programmable Valves used for hydrocephalus may not operate properly |
| May 16, 2013 | Class II | Z-0860-2014 | Device Design | Codman Certas Programmable Valves used for hydrocephalus may not operate properly |
| May 16, 2013 | Class II | Z-0861-2014 | Device Design | Codman Certas Programmable Valves used for hydrocephalus may not operate properly |
| May 16, 2013 | Class II | Z-0862-2014 | Device Design | Codman Certas Programmable Valves used for hydrocephalus may not operate properly |
| May 16, 2013 | Class II | Z-0859-2014 | Device Design | Codman Certas Programmable Valves used for hydrocephalus may not operate properly |
| May 16, 2013 | Class II | Z-0864-2014 | Device Design | Codman Certas Programmable Valves used for hydrocephalus may not operate properly |
The 5 latest of 16 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate K112156.
How does its category compare?
All JXG devicesJXG Shunt, Central Nervous System And Components: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JXG
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JXG
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JXG
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXG
1,198in 2025
MAUDE reports naming product code JXG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 184 | 0 | 649 |
| 2008 | 6 | 60 | 1 | 630 |
| 2009 | 5 | 106 | 30 | 629 |
| 2010 | 3 | 30 | 0 | 812 |
| 2011 | 7 | 136 | 5 | 787 |
| 2012 | 3 | 78 | 1 | 977 |
| 2013 | 3 | 108 | 14 | 1,004 |
| 2014 | 0 | — | 6 | 1,251 |
| 2015 | 6 | 276 | 0 | 984 |
| 2016 | 6 | 143 | 0 | 1,091 |
| 2017 | 7 | 90 | 1 | 1,335 |
| 2018 | 6 | 102 | 0 | 1,484 |
| 2019 | 4 | 101 | 0 | 1,295 |
| 2020 | 2 | — | 8 | 1,206 |
| 2021 | 1 | — | 0 | 1,467 |
| 2022 | 4 | 101 | 0 | 1,329 |
| 2023 | 5 | 134 | 2 | 1,221 |
| 2024 | 3 | 90 | 3 | 1,214 |
| 2025 | 8 | 255 | 0 | 1,198 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113526: Codman Certas Programmable Valve System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113526
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026