# K141776: Stratafix Symmetric PDS Plus Knotless Tissue Control Devices

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Oct 15, 2014 after 105 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
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device: named in the summary without a submission number

## 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
- K150553: Filbloc (2016), 2 descendants of its own
- K242835: Suture-TOOL System (2025), 1 descendant 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

## Indications for use
STRATAFIX™ Symmetric PDS™ Plus Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.

Source page: https://510kreport.com/device/K141776
Methodology: https://510kreport.com/methodology