# K252743: STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Dec 22, 2025 after 116 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K014153 (2002). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192144: STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, ETHICON, Inc. (2020) Summary page 5.
- K182873: STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices, ETHICON, Inc. (2019) Summary page 5.

## Indications for use
The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices are indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

Source page: https://510kreport.com/device/K252743
Methodology: https://510kreport.com/methodology