# K120816: Inzone Detachment System

- Pathway: 510(k) (Special)
- Applicant: Stryker
- Decided: Apr 17, 2012 after 29 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K951256 (1995). 35 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103008: Inzone Detachment System, Boston Scientific Corp (2010) Summary page 1.

## Most influential descendants
- K160096: InZone Detachment System (2016), 8 descendants of its own
- K203625: Numen Coil Embolization System; NumenFR Detachment System (2021), 3 descendants of its own
- K232955: Numen Coil Embolization System; NumenFR Detachment System (2024), 2 descendants of its own
- K242154: Numen™ Coil Embolization System; NumenFR™ Detachment System (2024), 1 descendant of its own
- K212455: InZone Detachment System (2021), 1 descendant of its own

## Indications for use
The lnZone Detachment System is intended for use with all versions of Stryker Neurovascular detachable coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

Source page: https://510kreport.com/device/K120816
Methodology: https://510kreport.com/methodology