# K024091: Silk Sutures

- Pathway: 510(k) (Traditional)
- Applicant: Aurolab
- Decided: Feb 28, 2003 after 79 days
- Product code: GAP (Suture, Nonabsorbable, Silk)
- Device class: 2
- Regulation: 21 CFR 878.5030
- Recalls of this device: none
- 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; 1 cites 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) Ethicon silk nonabsorbable sutures: named in the summary without a submission number

## Most influential descendants
- K041589: Arthrex Fiberwire with Silk (2004), 4 descendants of its own
- K071622: Arthrex Fiberwire (2007), 3 descendants of its own
- K252225: PowerKnot High Strength Sutures (2025), 0 descendants of its own
- K123668: Orthocord (2013), 0 descendants of its own
- K080918: Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet & 3 Free Strands of Size #2-0 (2008), 0 descendants of its own

## Indications for use
Aurolab nonabsorbable Silk suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Source page: https://510kreport.com/device/K024091
Methodology: https://510kreport.com/methodology