# K192144: STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Mar 25, 2020 after 230 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K014153 (2002). 46 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K120827: Quill Pdo Knotless Tissue-Closure Device (Polydixanone), Angiotech (2012) Summary page 5.

## Most influential descendants
- K252743: STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (2025), 0 descendants of its own

## Recalls of this device
- Aug 15, 2025 · Class II · Z-2605-2025: Potential for barb non-engagement.

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

Source page: https://510kreport.com/device/K192144
Methodology: https://510kreport.com/methodology