510(k) · Cleared
Recalled · Class II · 2024Certas Plus Programmable Valves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Production Corporation · JXG Shunt, Central Nervous System And Components
Cleared on Feb 1, 2023 as substantially equivalent to K152152 (Medos International SARL, 2015) and 1 other predicate after a 93-day review. Its family tree reaches back 4 generations to 1995. It has been recalled once.
- Decided
- Feb 1, 2023
- Review
- 93 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K944222 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 3 generations backK974739 Hakim Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
- 2 generations backK152152 Codman Certas Plus Programmable ValveMedos International SARL · 2015
- 1 generation backK182265 CodMan Certas Plus Programmable ValveIntegra Lifesciences Corp. · 2018
- This deviceK223330 Certas Plus Programmable ValvesIntegra Lifesciences Production Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944222 | Codman-Medos Valve Shunt System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −3 | K974739 | Hakim Programmable Valve System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −2 | K152152 | Codman Certas Plus Programmable Valve | Medos International SARL | 2015 | — |
| −1 | K182265 | CodMan Certas Plus Programmable Valve | Integra Lifesciences Corp. | 2018 | — |
| 0 (this device) | K223330 | Certas Plus Programmable Valves | Integra Lifesciences Production Corporation | 2023 | — |
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? (2)
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 |
|---|---|---|---|
| * | K152152 | Codman Certas Plus Programmable ValveSummary page 4…II Product Code JXG 807.92(a) (3) Predicate Information Predicate Device Certas Plus Programmable Valves: K152152 and K182265 Certas Plus Programmable Valves: K143111 (reference… | 2015 |
| * | K182265 | CodMan Certas Plus Programmable ValveSummary page 4…II Product Code JXG 807.92(a) (3) Predicate Information Predicate Device Certas Plus Programmable Valves: K152152 and K182265 Certas Plus Programmable Valves: K143111 (reference dev… | 2018 |
| † | K143111 | Codman Certas Plus Programmable Valve; Codman Certas Toll Kit | 2015 |
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 |
|---|---|---|---|---|
| Dec 16, 2024 | Class II | Z-0978-2025 | Labeling Change Control | Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K152152.
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. 2023, 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 Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223330 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223330: Certas Plus Programmable Valves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223330
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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