# K031168: Matrix Stretch Resistant Detachable Coil

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific, Target
- Decided: May 14, 2003 after 30 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001083 (2000). 3 ancestors in all.
100 later devices descend from it; 2 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012985: Matrix Detachable Coils, Boston Scientific, Target (2002) Summary page 1.
- K030475: GDC Stretch Resistant Detachable Coil, Boston Scientific, Target (2003)

## Most influential descendants
- K041551: Modification to: Hydrocoil Embolic System (Hes) (2004), 66 descendants of its own
- K050954: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) (2005), 65 descendants of its own
- K050700: Matrix Stretch Resistant (SR) Coils (2005), 59 descendants of its own
- K093142: Target Detachable Coils and Inzone Detachment System (2010), 58 descendants of its own
- K070656: Hydrocoil Embolic System (Hes) (2007), 36 descendants of its own

## Recalls of this device
- Oct 19, 2010 · Not classified · Z-0855-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Oct 19, 2010 · Not classified · Z-0856-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Oct 19, 2010 · Not classified · Z-0863-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Oct 19, 2010 · Not classified · Z-0860-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Oct 19, 2010 · Not classified · Z-0862-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Oct 19, 2010 · Not classified · Z-0854-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Oct 19, 2010 · Not classified · Z-0857-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Oct 19, 2010 · Not classified · Z-0858-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Oct 19, 2010 · Not classified · Z-0859-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Oct 19, 2010 · Not classified · Z-0861-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.

## Indications for use
Matrix Detachable Coils are intended for embolization of those intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable. Matrix Detachable Coils are also intended for embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Matrix Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K031168
Methodology: https://510kreport.com/methodology