510(k) · Cleared
ClearedPS Medical Strata NSC Lumboperitoneal Valve and Shunt System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Neurosurgery · JXG Shunt, Central Nervous System And Components
Cleared on Sep 2, 2009 as substantially equivalent to K033850 (Medtronic Neurosurgery, 2004) and 1 other predicate after a 121-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Sep 2, 2009
- Review
- 121 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K944222 (1995). 11 ancestors in all, the oldest K831396 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 4 generations backK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
- 3 generations backK980778 Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
- 2 generations backK012052 Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002
- 1 generation backK033850 Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and…Medtronic Neurosurgery · 2004 · Recalled
- This deviceK091312 PS Medical Strata NSC Lumboperitoneal Valve and Shunt SystemMedtronic Neurosurgery · 2009
- Descendant · cites it directly · 0 of its ownK123524 Medtronic Strata NSC Lumboperitoneal Valve and Shunt SystemMedtronic Neurosurgery · 2013 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K123524Medtronic Strata NSC Lumboperitoneal Valve and Shunt SystemMedtronic Neurosurgery · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944222 | Codman-Medos Valve Shunt System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −4 | K973774 | Codman Hakim Micro Precision Valve | Johnson & Johnson Professionals, Inc. | 1997 | — |
| −3 | K980778 | Hakim Micro Programmable Valve System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −2 | K012052 | Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 | Medtronic PS Medical | 2002 | — |
| −1 | K033850 | Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without… | Medtronic Neurosurgery | 2004 | 2 |
| 0 (this device) | K091312 | PS Medical Strata NSC Lumboperitoneal Valve and Shunt System | Medtronic Neurosurgery | 2009 | — |
| +1 | K123524 | Medtronic Strata NSC Lumboperitoneal Valve and Shunt System | Medtronic Neurosurgery | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (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 |
|---|---|---|---|
| * | K033850 | Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without BioglideSummary page 1…fication: *'PS Medical® Strata® NSC Valve and Shunt Assemblies with and without BioGlide (K033850) CSF-Lumboperitoneal Shunt System (K831396) Device Description… | 2004 |
| * | K831396 | P-S Medical CSF-Lumboperitoneal ShuntSummary page 1…Assemblies with and without BioGlide (K033850) CSF-Lumboperitoneal Shunt System (K831396) Device Description PS Medical® Strata® NSC Lumboperitoneal Valve and Shunt System are designed for diversion… | 1983 |
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 |
|---|---|---|---|
| K123524 | Medtronic Strata NSC Lumboperitoneal Valve and Shunt System | 2013 | 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 14 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K123524 (Medtronic Neurosurgery, 2013) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K033850.
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. 2009, 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 Strata NSC Lumboperitoneal Shunt System provides continued cerebrospinal fluid (CSF) flow from the subarachnoid space into the peritoneal cavity. The Strata NSC Lumboperitoneal Valve allows the physician to non-invasively adjust the pressure/flow performance level pre- and post-implantation without the need for radiographic confirmation in order to address changing patient needs. The Strata NSC Lumboperitoneal Shunt System is designed for management of communicating hydrocephalus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091312 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091312: PS Medical Strata NSC Lumboperitoneal Valve and Shunt System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091312
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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