# K990088: Synthofil Nonabsorbable Pet Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Feb 10, 1999 after 30 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
275 later devices descend from it; 3 cite it directly.
0 of 276 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) Ethibond® Nonabsorbable Polyester Surgical Suture (Ethicon, Inc.): named in the summary without a submission number
- (no number) Ti-Cron® Nonabsorbable Polyester Surgical Suture (Davis & Geck): named in the summary without a submission number
- (no number) SURGIDAC® Nonabsorbable PET Surgical Suture (U. S. Surgical Corp.): named in the summary without a submission number

## Most influential descendants
- K012923: Arthrex Fiberwire, Usp Size 5, Model AR-7201 (2001), 260 descendants of its own
- K021434: Arthrex Fiberwire in Usp Sizes (2002), 259 descendants of its own
- K031666: Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS (2003), 161 descendants of its own
- K062747: Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM (2006), 143 descendants of its own
- K063778: Force Fiber Polyethylene Nonabsorbable Suture (2007), 69 descendants of its own

## Indications for use
Synthofil® 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/K990088
Methodology: https://510kreport.com/methodology