STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
FDA 510(k) K252743 · ETHICON, Inc.
510(k) numberK252743
Submission
- Device name
- STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
- Applicant
- ETHICON, Inc.
Raritan, NJ, US - Received
- August 28, 2025
- Decision date
- December 22, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4493
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253394 | Coated VICRYL (Polyglactin 910) Plus Antibacterial SutureGAM · Traditional | ETHICON, Inc. | 06/25/2026SE |
| K253530 | Trexon Monofilament Synthetic Absorbable SutureGAM · Traditional | Medtronic | 05/28/2026SE |
| K253852 | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic…GAM · Traditional | ETHICON, Inc. | 02/06/2026SE |
| K253620 | TroClose 1200GAM · Special | Gordian Surgical, Ltd. | 12/16/2025SE |
| K252820 | PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90…GAM · Special | Internacional Farmacéutica S.A DE C.V | 10/03/2025SE |
| K233265 | Monotime and Optime RGAM · Abbreviated | Peters Surgical | 10/11/2024SE |
| K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)GAM · Abbreviated | Peters Surgical | 07/12/2024SE |
| K221527 | StitchKitGAM · Traditional | Origami Surgical Inc . | 02/14/2023SE |
| K221744 | STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control DeviceGAM · Traditional | ETHICON, Inc. | 11/15/2022SE |
| K212810 | MONOFIX PGCL, knotless wound closure deviceGAM · Traditional | Samyang Holdings Corp., Ltd. | 08/05/2022SE |
More from Samyang Holdings Corp., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253394 | Coated VICRYL (Polyglactin 910) Plus Antibacterial SutureGAM · Traditional | 06/25/2026SE |
| K252047 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control DevicesNEW · Traditional | 05/18/2026SE |
| 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 |
| 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 Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device cleared by the FDA?
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device (K252743) received a 510(k) decision of Substantially Equivalent on December 22, 2025, 116 days after the submission was received.
What is the product code of K252743?
The FDA product code is GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid, a Class II (moderate risk) device regulated under 21 CFR 878.4493.