# K032420: Modified Coated Vicryl Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Oct 22, 2003 after 78 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
29 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Coated VICRYL* Plus Antibacterial (Polyglactin 910) Suture: named in the summary without a submission number

## Most influential descendants
- K050845: Monocryl Plus Antibacterial Suture (2005), 25 descendants of its own
- K061037: PDS Plus Antibacterial Suture (2006), 21 descendants of its own
- K151200: STRATAFIX  Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device (2015), 8 descendants of its own
- K150670: STRATAFIX Spiral PDS Plus Knotless Tissue Control Device (2015), 8 descendants of its own
- K182873: STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices (2019), 7 descendants of its own

## Recalls of this device
- Feb 2, 2009 · Not classified · Z-1310-2009: Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.

## Indications for use
Modified Coated VICRYL* Plus Antibacterial suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.

Source page: https://510kreport.com/device/K032420
Methodology: https://510kreport.com/methodology