# K050845: Monocryl Plus Antibacterial Suture

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Jun 29, 2005 after 86 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
Longest line of descent: 1 generation back to K960653 (1996). 3 ancestors in all.
25 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960653: Monocryl (Poliglecaprone 25) Suture, Dyed (Modified), ETHICON, Inc. (1996) Summary page 1.
- K964072: Monocryl (Poliglecaprone 25) Suture, Undyed, ETHICON, Inc. (1996) Summary page 1.
- K032420: Modified Coated Vicryl Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture, ETHICON, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K100461: PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic Gut (2010), 5 descendants of its own

## Recalls of this device
- Feb 2, 2009 · Not classified · Z-1312-2009: 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
MONOCRYL* Plus Antibacterial (poliglecaprone 25) sutures (dyed or undyed) are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Source page: https://510kreport.com/device/K050845
Methodology: https://510kreport.com/methodology