# 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

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Jan 10, 2019 after 90 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K014153 (2002). 45 ancestors in all.
7 later devices descend from it; 6 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141776: Stratafix Symmetric PDS Plus Knotless Tissue Control Devices, ETHICON, Inc. (2014) Summary page 8.
- K150670: STRATAFIX Spiral PDS Plus Knotless Tissue Control Device, ETHICON, Inc. (2015) Summary page 8.
- K151200: STRATAFIX  Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device, ETHICON, Inc. (2015) Summary page 8.

## Most influential descendants
- 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
- 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 28, 2019 · Class II · Z-1335-2020: The product do not meet certain internal testing specifications.
- Aug 28, 2019 · Class II · Z-1334-2020: The product do not meet certain internal testing specifications.
- Aug 28, 2019 · Class II · Z-1336-2020: The product do not meet certain internal testing specifications.
- Aug 13, 2019 · Class II · Z-0048-2020: The product does not meet certain internal strength testing specifications.
- Aug 13, 2019 · Class II · Z-0047-2020: The product does not meet certain internal strength testing specifications.

## Indications for use
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate. STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

Source page: https://510kreport.com/device/K182873
Methodology: https://510kreport.com/methodology