# K101381: Horizontal-Vertical Lumbar Valve and Spetzler Lumbar Peritoneal Shunt Systems

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Jul 7, 2011 after 416 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K811288 (1981). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944595: Cordis Horizontal-Verical Valve System, Cordis Corp. (1995) Summary page 1.
- K811288: Spetzler Lumbar-Peritoneal System, American Heyer Schulte (1981) Summary page 1.
- K871685: Heyer-Schulte Spetzler Lumbar-Peritoneal Shunt Sys, American V. Mueller (1987) Summary page 1.

## Most influential descendants
- K161992: Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems (2016), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K101381
Methodology: https://510kreport.com/methodology