510(k) · Cleared
ClearedOrbis-Sigma Valve System for Ventricular Shunting
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · JXG Shunt, Central Nervous System And Components
Cleared on Dec 12, 1991 after a 119-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Dec 12, 1991
- Review
- 119 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK913636 Orbis-Sigma Valve System for Ventricular ShuntingCordis Corp. · 1991
- Descendant · cites it directly · 5 of its ownK971799 Precision Flow Osv IIElekta Implants, SA · 1998
- Descendant · 2 generations on · 3 of its ownK042192 Low Flow Osv II Hydrocephalus ValveIntegra Neurosciences Implants S.A. · 2004
- Descendant · 2 generations on · 2 of its ownK081773 OSV IIIntegra Neurosciences Implants S.A. · 2008
- Descendant · 3 generations on · 1 of its ownK093968 Osv II Low Flow Low Pro ValveIntegra LifeSciences Corporation · 2010
- Descendant · 2 generations on · 1 of its ownK092395 Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve SystemIntegra Lifesciences Corp. · 2009
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K971799Precision Flow Osv IIElekta Implants, SA · 1998 · cites it directly5descendants
- K042192Low Flow Osv II Hydrocephalus ValveIntegra Neurosciences Implants S.A. · 2004 · 2 generations on3descendants
- K081773OSV IIIntegra Neurosciences Implants S.A. · 2008 · 2 generations on2descendants
- K093968Osv II Low Flow Low Pro ValveIntegra LifeSciences Corporation · 2010 · 3 generations on1descendant
- K092395Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve SystemIntegra Lifesciences Corp. · 2009 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913636 | Orbis-Sigma Valve System for Ventricular Shunting | Cordis Corp. | 1991 | — |
| +1 | K971799 | Precision Flow Osv II | Elekta Implants, SA | 1998 | — |
| +2 | K042192 | Low Flow Osv II Hydrocephalus Valve | Integra Neurosciences Implants S.A. | 2004 | — |
| +2 | K081773 | OSV II | Integra Neurosciences Implants S.A. | 2008 | — |
| +3 | K093968 | Osv II Low Flow Low Pro Valve | Integra LifeSciences Corporation | 2010 | — |
| +2 | K092395 | Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve System | Integra Lifesciences Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K971799 (Elekta Implants, SA, 1998) has gone furthest, with 5 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K913636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913636: Orbis-Sigma Valve System for Ventricular Shunting.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913636
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026