STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices
FDA 510(k) K252047 · ETHICON, Inc.
510(k) numberK252047
Submission
- Device name
- STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices
- Applicant
- ETHICON, Inc.
Raritan, NJ, US - Received
- June 30, 2025
- Decision date
- May 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEW – Suture, Surgical, Absorbable, Polydioxanone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4840
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code NEW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253879 | Monofix PdoNEW · Traditional | Samyang Holdings Corporation | 08/25/2026SE |
| K261988 | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureNEW · Special | Teleflex Medical, LLC | 07/09/2026SE |
| K252171 | Barbed PDO SutureNEW · Traditional | Sutura Medical Technology, Inc. | 06/12/2026SE |
| K243897 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureNEW · Traditional | ETHICON, Inc. | 11/12/2025SE |
| K251414 | Miracu Polydioxanone (PDO) Suture and Needle (MONO)NEW · Traditional | Feeltech Co., Ltd. | 10/20/2025SE |
| K250107 | V-soft Line Barbed Surgical Suture (Various)NEW · Traditional | Feeltech Co., Ltd. | 10/15/2025SE |
| K252644 | PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION…NEW · Special | M/s. Meril Endo Surgery Private Limited. | 09/23/2025SE |
| K250977 | Suture-TOOL SystemNEW · Special | Suturion AB | 04/28/2025SE |
| K242835 | Suture-TOOL SystemNEW · Traditional | Suturion AB | 01/22/2025SE |
| K242571 | Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150…NEW · Special | Hyundae Meditech Co., Ltd. | 09/27/2024SE |
More from Hyundae Meditech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253394 | Coated VICRYL (Polyglactin 910) Plus Antibacterial SutureGAM · Traditional | 06/25/2026SE |
| K253572 | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX…GAW · Traditional | 03/27/2026SE |
| K253852 | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic…GAM · Traditional | 02/06/2026SE |
| K252743 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL…GAM · Traditional | 12/22/2025SE |
| K243897 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureNEW · Traditional | 11/12/2025SE |
| K221744 | STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control DeviceGAM · Traditional | 11/15/2022SE |
| K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical SutureNEW · Traditional | 02/22/2022SE |
| K213512 | DERMABOND PRINEO Skin Closure SystemOMD · Special | 12/07/2021SE |
| K201996 | Monocryl Plus Antibacterial SutureGAM · Traditional | 12/21/2020SE |
| K201686 | GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT…OTN · Traditional | 09/17/2020SE |
Questions and answers
When was STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices cleared by the FDA?
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices (K252047) received a 510(k) decision of Substantially Equivalent on May 18, 2026, 322 days after the submission was received.
What is the product code of K252047?
The FDA product code is NEW – Suture, Surgical, Absorbable, Polydioxanone, a Class II (moderate risk) device regulated under 21 CFR 878.4840.