510(k) · Cleared
ClearedCodman Certas Plus Programmable Valve; Codman Certas Toll Kit
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 19, 2015 as substantially equivalent to K112156 (Medos International SARL, 2011) after a 113-day review. Its family tree reaches back 8 generations to 1995. 1 later device descends from it.
- Decided
- Feb 19, 2015
- Review
- 113 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K944222 (1995). 15 ancestors in all, the oldest K861377 (1986). 1 later device descends from it, 1 citing it directly.
- 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 deviceK143111 Codman Certas Plus Programmable Valve; Codman Certas Toll KitMedos International SARL · 2015
- Descendant · cites it directly · 0 of its ownK181902 Codman Certas Plus Electronic Tool KitIntegra Lifesciences Corp. · 2018
Most influential descendants
Showing 1 of 1 · See all- K181902Codman Certas Plus Electronic Tool KitIntegra Lifesciences Corp. · 2018 · cites it directly0descendants
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) | K143111 | Codman Certas Plus Programmable Valve; Codman Certas Toll Kit | Medos International SARL | 2015 | — |
| +1 | K181902 | Codman Certas Plus Electronic Tool Kit | Integra Lifesciences Corp. | 2018 | — |
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 |
|---|---|---|
| 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? (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 4…Product Code JXG III. Predicate Codman Certas Programmable Valve System and Codman Certas Therapy Device Management System (K112156) IV. Device The Codman Certas Plus Programmable Valve is a sterile, single use, Description implantable device desig… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181902 | Codman Certas Plus Electronic Tool Kit | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 6 of the 15 ancestors have a recall of any class.
- Of its descendants, K181902 (Integra Lifesciences Corp., 2018) has gone furthest, with 0 descendants of its own.
- 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. 2015, 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 Plus Programmable Valve is an implantable device that provides constant intraventricular pressure
and drainage of CSF for the management of hydrocephalus.
The Codman Certas Tool Kit allows the noninvasive reading or adjustment of the valve setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143111 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143111: Codman Certas Plus Programmable Valve; Codman Certas Toll Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143111
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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