510(k) · Cleared
ClearedHorizontal-Vertical Lumbar Valve and Spetzler Lumbar Peritoneal Shunt Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · JXG Shunt, Central Nervous System And Components
Cleared on Jul 7, 2011 as substantially equivalent to K944595 (Cordis Corp., 1995) and 2 other predicates after a 416-day review. Its family tree reaches back 1 generation to 1981. 1 later device descends from it.
- Decided
- Jul 7, 2011
- Review
- 416 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K811288 (1981). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK811288 Spetzler Lumbar-Peritoneal SystemAmerican Heyer Schulte · 1981 · Recalled
- This deviceK101381 Horizontal-Vertical Lumbar Valve and Spetzler Lumbar Peritoneal…Integra LifeSciences Corporation · 2011
- Descendant · cites it directly · 0 of its ownK161992 Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal…Integra LifeSciences Corporation · 2016
Most influential descendants
Showing 1 of 1 · See all- K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsIntegra LifeSciences Corporation · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811288 | Spetzler Lumbar-Peritoneal System | American Heyer Schulte | 1981 | 5 |
| 0 (this device) | K101381 | Horizontal-Vertical Lumbar Valve and Spetzler Lumbar Peritoneal Shunt Systems | Integra LifeSciences Corporation | 2011 | — |
| +1 | K161992 | Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt… | Integra LifeSciences Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (3)
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 |
|---|---|---|---|
| * | K944595 | Cordis Horizontal-Verical Valve SystemSummary page 1…, Central Nervous System and Components, JXG 3. Legallv Marketed Predicate Device(s) 510(k) Number Product Code Trade Name Manufacturer K944595 JXG Cordis Horizontal-Vertical Integra LifeSciences Valve S… | 1995 |
| * | K811288 | Spetzler Lumbar-Peritoneal SystemSummary page 1…G Cordis Horizontal-Vertical Integra LifeSciences Valve System (Previously Cordis Corp.) K81 1288 JXG Spetzler Lumbar-Peritoneal Integra LifieSciences Systems… | 1981 |
| * | K871685 | Heyer-Schulte Spetzler Lumbar-Peritoneal Shunt SysSummary page 1…Systems (Previously American Heyer-Schulte Corp.) K87 1685 JXG Heyer-Schulte Spetzler Integra LifieSciences Lumbar-… | 1987 |
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 |
|---|---|---|---|
| K161992 | Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems | 2016 | 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?
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. 2011, 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?
Horizontal-Vertical Lumbar Valve Systems are implantable devices used in the treatment of patients with communicating hydrocephalus to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid region to the peritoneal cavity. They provide controlled intraventricular pressure and CSF drainage in patients with hydrocephalus. The antechamber can be electively mounted in line with the Valve Unit to allow for CSF sampling or injections in the subarachnoid…
Read the full statement (186 words)
Horizontal-Vertical Lumbar Valve Systems are implantable devices used in the treatment of patients with communicating hydrocephalus to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid region to the peritoneal cavity. They provide controlled intraventricular pressure and CSF drainage in patients with hydrocephalus. The antechamber can be electively mounted in line with the Valve Unit to allow for CSF sampling or injections in the subarachnoid space.
Percutaneous lumbar peritonea] shunting may be utilized in the treatment of communicating hydrocephalus. It is designed to' shunt CSF from the lumbar subarachnoid space to the peritoneal cavity.
The shunt may be used for diagnosis, evaluation or treatment of normal pressure communicating hydrocephalus.
A percutaneous lumbar peritoneal shunt is also useful in the management of persistent cerebrospinal fluid fistulas, bulging cranial and suboccipital decompressions and in transient CSF absorption defects, e.g. post-meningitic or post-hemorrhagic hydrocephalus.
The In-Line Valve, available as a separate component of the system, is indicated for use where added resistance is desired to alleviate symptoms of low pressure in the small percentage of patients who, after normal drainage and in the normal course of treatment, develop such symptoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101381: Horizontal-Vertical Lumbar Valve and Spetzler Lumbar Peritoneal Shunt Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101381
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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