# K990090: Dafilon Nonabsorbable Polyamide Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Mar 22, 1999 after 70 days
- Product code: GAR (Suture, Nonabsorbable, Synthetic, Polyamide)
- Device class: 2
- Regulation: 21 CFR 878.5020
- 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 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) Ethilon® Nonabsorbable Polyamide Surgical Suture: named in the summary without a submission number
- (no number) DERMALON® Nonabsorbable Polyamide Surgical Suture: named in the summary without a submission number
- (no number) MONOSOF® Nonabsorbable Polyamide Surgical Suture: named in the summary without a submission number

## Most influential descendants
- K151165: Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture (2016), 3 descendants of its own
- K192420: Crownjun Nylon Suture (2020), 1 descendant of its own
- K221280: Vesseal (2022), 0 descendants of its own
- K212603: Non Absorbable Surgical Nylon Suture (2021), 0 descendants of its own
- K060528: Aesculap Trelon Nonabsorbable Multifilament Polyamide Surgical Suture (2006), 0 descendants of its own

## Recalls of this device
- Jun 13, 2014 · Class II · Z-2024-2014: Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4 non-sterile non-absorbable polyamide Surgical Suture due to a labeling issue. Box labels do state non-

## Indications for use
Dafilon® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Source page: https://510kreport.com/device/K990090
Methodology: https://510kreport.com/methodology