# K000541: Silk Nonabsorbable Surgical Sutures, Usp

- Pathway: 510(k) (Traditional)
- Applicant: Arc Medical Supplies (Beijing) Co, Ltd.
- Decided: Apr 28, 2000 after 71 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.
40 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012124: Mersilk Black Silk Braided Non-Absorbable Suture, Usp (2001), 39 descendants of its own
- K032245: Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape (TM), 4MM, Models AR-7237, AR-7238, AR-7239 (2004), 37 descendants of its own
- K041553: Arthrex Suture Grafting Kit (2004), 31 descendants of its own
- K122374: Arthrex Suture (Uhmwpe) (2012), 13 descendants of its own
- K143702: Arthrex Blunt Tip Screws with Fiber Tape (2015), 4 descendants of its own

Source page: https://510kreport.com/device/K000541
Methodology: https://510kreport.com/methodology