# K150670: STRATAFIX Spiral PDS Plus Knotless Tissue Control Device

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Jul 2, 2015 after 108 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K014153 (2002). 28 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061037: PDS Plus Antibacterial Suture, ETHICON, Inc. (2006) Summary page 4.
- K123877: Quill Pdo Knotless Tissue-Closure Device, Variable Loop Design, Surgical Specialties Corp. Dba Angiotech (2013) Summary page 4.
- K113744: Quill Pdo Knotless Tissue-Closure Device (Polydioxanone), Angiotech (2012) Summary page 4.
- K120827: Quill Pdo Knotless Tissue-Closure Device (Polydixanone), Angiotech (2012) Summary page 4.

## Most influential descendants
- 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 (2019), 7 descendants of its own
- K221744: STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (2022), 2 descendants of its own
- K232246: 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture (2024), 1 descendant of its own
- K192144: STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device (2020), 1 descendant of its own
- K252047: STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices (2026), 0 descendants of its own

## Indications for use
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Source page: https://510kreport.com/device/K150670
Methodology: https://510kreport.com/methodology