# K253572: STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device  STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Mar 27, 2026 after 130 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: 12 generations back to K014153 (2002). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052373: Quill Nonabsorbable Polypropylene Barbed Suture, Quill Medical, Inc. (2005) Summary page 5.
- K151112: Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design, Angiotech (2015) Summary page 5.

## Indications for use
The STRATAFIX™ Spiral PRONOVA™ Unidirectional Device is indicated for use in soft tissue approximation where the use of a non-absorbable barbed suture is appropriate, excluding closure of the epidermis. The STRATAFIX™ Spiral PRONOVA™ Bidirectional Device is indicated for use in soft tissue approximation where the use of a non-absorbable barbed suture is appropriate, excluding closure of the epidermis.

Source page: https://510kreport.com/device/K253572
Methodology: https://510kreport.com/methodology