510(k) · Cleared
Recalled · Class II · 2014Codman Certas Programmable Valve System, Codman Certas Therapy Management 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 Oct 17, 2011 as substantially equivalent to K974739 (Johnson & Johnson Professionals, Inc., 1998) and 3 other predicates after an 82-day review. Its family tree reaches back 7 generations to 1995. 3 later devices descend from it. It has been recalled 16 times.
- Decided
- Oct 17, 2011
- Review
- 82 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 16
- Predicates
- 4
Its longest line of descent runs back 7 generations to K944222 (1995). 14 ancestors in all, the oldest K861377 (1986). 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 6 generations backK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
- 5 generations backK980778 Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
- 4 generations backK012052 Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002
- 3 generations backK033850 Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and…Medtronic Neurosurgery · 2004 · Recalled
- 2 generations backK042465 PS Medical Strata II ValveMedtronic Neurosurgery · 2004 · Recalled
- 1 generation backK060681 Medtronic PS Medical Strata Type ValueMedtronic Neurosurgery · 2006 · Recalled
- This deviceK112156 Codman Certas Programmable Valve System, Codman Certas Therapy…Medos International SARL · 2011
- Descendant · cites it directly · 1 of its ownK143111 Codman Certas Plus Programmable Valve; Codman Certas Toll KitMedos International SARL · 2015
- Descendant · 2 generations on · 0 of its ownK181902 Codman Certas Plus Electronic Tool KitIntegra Lifesciences Corp. · 2018
- Descendant · cites it directly · 0 of its ownK113526 Codman Certas Programmable Valve SystemMedos International SARL · 2012 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K143111Codman Certas Plus Programmable Valve; Codman Certas Toll KitMedos International SARL · 2015 · cites it directly1descendant
- K181902Codman Certas Plus Electronic Tool KitIntegra Lifesciences Corp. · 2018 · 2 generations on0descendants
- K113526Codman Certas Programmable Valve SystemMedos International SARL · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K944222 | Codman-Medos Valve Shunt System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −6 | K973774 | Codman Hakim Micro Precision Valve | Johnson & Johnson Professionals, Inc. | 1997 | — |
| −5 | K980778 | Hakim Micro Programmable Valve System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −4 | K012052 | Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 | Medtronic PS Medical | 2002 | — |
| −3 | K033850 | Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without… | Medtronic Neurosurgery | 2004 | 2 |
| −2 | K042465 | PS Medical Strata II Valve | Medtronic Neurosurgery | 2004 | 4 |
| −1 | K060681 | Medtronic PS Medical Strata Type Value | Medtronic Neurosurgery | 2006 | 2 |
| 0 (this device) | K112156 | Codman Certas Programmable Valve System, Codman Certas Therapy Management System | Medos International SARL | 2011 | — |
| +1 | K143111 | Codman Certas Plus Programmable Valve; Codman Certas Toll Kit | Medos International SARL | 2015 | — |
| +2 | K181902 | Codman Certas Plus Electronic Tool Kit | Integra Lifesciences Corp. | 2018 | — |
| +1 | K113526 | Codman Certas Programmable Valve System | Medos International SARL | 2012 | 16 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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? (4)
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 |
|---|---|---|---|
| * | K974739 | Hakim Programmable Valve SystemSummary page 1…ion: Class 11(JXG) Central Nervous System Fluid Shunt and Components Legally Marketed Predicate Devices: K<974739 - Codman Hakim Programmable Valve K091 346- Codman Hakim Shunt System… | 1998 |
| * | K060681 | Medtronic PS Medical Strata Type ValueSummary page 1…K<992173 - Codman SIPHONGUARD CSF Control Device K003322 - Codman Bactiseal Catheters K<060681 - Medtronic PS Medical® Strata® Type® Valve K040943 - Medtronic PS Strata® Valves and Handtoo… | 2006 |
| * | K040943 | Medtronic PS Medical Strata ValveSummary page 1…K003322 - Codman Bactiseal Catheters K<060681 - Medtronic PS Medical® Strata® Type® Valve K040943 - Medtronic PS Strata® Valves and Handtools K<090342 - Sophysa Polaris Device Description:… | 2004 |
| * | K090342 | Polaris Pressure Adjustable Valve, Models SPV, Spva, SPVB, SPV-140, SPV-300, SPV-400Summary page 1…K<060681 - Medtronic PS Medical® Strata® Type® Valve K040943 - Medtronic PS Strata® Valves and Handtools K<090342 - Sophysa Polaris Device Description: The Certas Programmable Valve System is designed for shunting… | 2009 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 14 ancestors have a recall of any class.
- Of its descendants, K143111 (Medos International SARL, 2015) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K974739.
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. 2011, 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 setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112156: Codman Certas Programmable Valve System, Codman Certas Therapy Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112156
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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