# K223330: Certas Plus Programmable Valves

- Pathway: 510(k) (Traditional)
- Applicant: Integra Lifesciences Production Corporation
- Decided: Feb 1, 2023 after 93 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K944222 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152152: Codman Certas Plus Programmable Valve, Medos International SARL (2015) Summary page 4.
- K182265: CodMan Certas Plus Programmable Valve, Integra Lifesciences Corp. (2018) Summary page 4.

## Recalls of this device
- Dec 16, 2024 · Class II · Z-0978-2025: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.

## Indications for use
The Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

Source page: https://510kreport.com/device/K223330
Methodology: https://510kreport.com/methodology