# K133890: Aesculap Optilene Nonabsorbable Suture

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jul 15, 2014 after 207 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K954808 (1996). 5 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980703: Premilene Nonabsorbable Polypropylene Surgical Suture, Aesculap, Inc. (1998) Summary page 1.
- K050947: Modification to: Modified Uss Polypropylene Suture, United States Surgical, A Division of Tyco Healthc (2005) Summary page 1.
- K954808: Ussc Polyproplene Suture, United States Surgical, A Division of Tyco Healthc (1996) Summary page 1.
- K012201: Premicron Nonabsorbable Pet Surgical Suture, Aesculap, Inc. (2001) Summary page 1.

## Cited in the summary but kept off the family tree
- K016374: Prolene Polypropylene Nonabsorbable Surgical Suture. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K001909: Plainsense Wheelchair, Plainsense Wheelchairs, Inc. (2000). Our OCR of the scanned summary read K001909, FDA’s number for Plainsense Wheelchair (Plainsense Wheelchairs, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “USS Polypropylene Suture”. Kept off the family tree.

## 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
- K180321: Aesculap Optilene Nonabsorbable Suture (2018), 0 descendants of its own

## Indications for use
Optilene Nonabsorbable Polypropylene/Polyethylene Surgical sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.

Source page: https://510kreport.com/device/K133890
Methodology: https://510kreport.com/methodology