510(k) · Cleared
ClearedOSV II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Neurosciences Implants S.A. · JXG Shunt, Central Nervous System And Components
Cleared on Nov 6, 2008 as substantially equivalent to K971799 (Elekta Implants, SA, 1998) after a 136-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it.
- Decided
- Nov 6, 2008
- Review
- 136 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913636 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK913636 Orbis-Sigma Valve System for Ventricular ShuntingCordis Corp. · 1991
- 1 generation backK971799 Precision Flow Osv IIElekta Implants, SA · 1998
- This deviceK081773 OSV IIIntegra Neurosciences Implants S.A. · 2008
- Descendant · cites it directly · 1 of its ownK092395 Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve SystemIntegra Lifesciences Corp. · 2009
- Descendant · cites it directly · 0 of its ownK140722 Integra Flow Regulating Valve Systems Osv II Models and Integra Flow…Integra LifeSciences Corporation · 2015
Most influential descendants
Showing 2 of 2 · See all- K092395Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve SystemIntegra Lifesciences Corp. · 2009 · cites it directly1descendant
- K140722Integra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve…Integra LifeSciences Corporation · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913636 | Orbis-Sigma Valve System for Ventricular Shunting | Cordis Corp. | 1991 | — |
| −1 | K971799 | Precision Flow Osv II | Elekta Implants, SA | 1998 | — |
| 0 (this device) | K081773 | OSV II | Integra Neurosciences Implants S.A. | 2008 | — |
| +1 | K092395 | Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve System | Integra Lifesciences Corp. | 2009 | — |
| +1 | K140722 | Integra Flow Regulating Valve Systems Osv II Models and Integra Flow… | Integra LifeSciences Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K971799 | Precision Flow Osv II Our reading of the summary gave K911799, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “OSV II”. | 1998 |
What descends from it? (2)
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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K092395 (Integra Lifesciences Corp., 2009) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K971799.
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. 2008, 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 OSV II is an implantable system used in the treatment of patients with
hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other
appropriate drainage site such as the heart's right atrium.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081773 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081773: OSV II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081773
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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