# K041514: Truesilk Non-Absorbable Silk Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Sutures India Private Limited
- Decided: Jun 3, 2005 after 361 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
Longest line of descent: 1 generation back to K960328 (1996). 2 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990089: Silkam Nonabsorbable Silk Surgical Suture, Aesculap, Inc. (1999) Summary page 1.
- K960328: Silk Nonabsorbable Surgical Sutures Usp, R. K. Medical L. L. C. (1996) Summary page 1.

## Most influential descendants
- K080684: WG-Surgical Sutures with Needle (2008), 9 descendants of its own
- K161633: Rexlon, Rexsil (2017), 4 descendants of its own
- K160623: FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture (2016), 2 descendants of its own
- K173747: Rexlene (2018), 1 descendant of its own
- K180701: SafePath Suturing System (2018), 1 descendant of its own

## Indications for use
TRUSILK Non-absorbable Silk Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

Source page: https://510kreport.com/device/K041514
Methodology: https://510kreport.com/methodology