510(k) · Cleared
ClearedHorizontal-Vertical Lumbar Valve Systems, 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 Sep 22, 2016 as substantially equivalent to K101381 (Integra LifeSciences Corporation, 2011) after a 65-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Sep 22, 2016
- Review
- 65 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K811288 (1981). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK811288 Spetzler Lumbar-Peritoneal SystemAmerican Heyer Schulte · 1981 · Recalled
- 1 generation backK101381 Horizontal-Vertical Lumbar Valve and Spetzler Lumbar Peritoneal…Integra LifeSciences Corporation · 2011
- This deviceK161992 Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal…Integra LifeSciences Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K811288 | Spetzler Lumbar-Peritoneal System | American Heyer Schulte | 1981 | 5 |
| −1 | K101381 | Horizontal-Vertical Lumbar Valve and Spetzler Lumbar Peritoneal Shunt Systems | Integra LifeSciences Corporation | 2011 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K101381 | Horizontal-Vertical Lumbar Valve and Spetzler Lumbar Peritoneal Shunt SystemsSummary page 4…(a)(3) - Legally marketed device(s) to which equivalence is claimed Predicate device: Horizontal-Ventricular Lumbar Valves and Spetzler Lumbar Peritoneal Shunt Systems; K101381 Reference device: Integra DP Valve Systems (Including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating… | 2011 |
| † | K152897 | Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 2 companies; a new generation was cleared every 30.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
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. 2016, 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 peritoneal 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/K161992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161992: Horizontal-Vertical Lumbar Valve Systems, 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/K161992
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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