NEW · Suture, Surgical, Absorbable, Polydioxanone
General, Plastic Surgery · 21 CFR 878.4840 · Class 2
Overview
| Product Code | NEW |
|---|---|
| Device Name | Suture, Surgical, Absorbable, Polydioxanone |
| Regulation | 21 CFR 878.4840 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.
Classification Rationale
Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
Recent Cleared Devices (20 of 62)
Showing 20 most recent of 62 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243897 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. | Nov 12, 2025 | SESE |
| K251414 | Miracu Polydioxanone (PDO) Suture and Needle (MONO) | Feeltech Co., Ltd. | Oct 20, 2025 | SESE |
| K250107 | V-soft Line Barbed Surgical Suture (Various) | Feeltech Co., Ltd. | Oct 15, 2025 | SESE |
| K252644 | PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture | M/s. Meril Endo Surgery Private Limited. | Sep 23, 2025 | SESE |
| K250977 | Suture-TOOL System | Suturion AB | Apr 28, 2025 | SESE |
| K242835 | Suture-TOOL System | Suturion AB | Jan 22, 2025 | SESE |
| K242571 | Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938 | Hyundae Meditech Co., Ltd. | Sep 27, 2024 | SESE |
| 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 | M/s. Meril Endo Surgery Private Limited. | Apr 25, 2024 | SESE |
| K240389 | Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150) | Hyundae Meditech Co., Ltd. | Mar 27, 2024 | SESE |
| K220549 | MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 | Hans Biomed Corporation | Mar 7, 2023 | SESE |
| K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture | ETHICON, Inc. | Feb 22, 2022 | SESE |
| K210871 | PDO Max Suture with Dual Needle | Pdo Max, Inc. | Dec 17, 2021 | SESE |
| K201139 | WEGO-PDO Barbed Suture | Foosin Medical Supplies Inc., Ltd. | Oct 20, 2020 | SESE |
| K192423 | MINT Product Family | Hans Biomed Corporation | Sep 9, 2020 | SESE |
| K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | Mar 25, 2020 | SESE |
| K191361 | DemeDIOX Barbed Absorbable Surgical Suture | Demetech Corporation | Nov 7, 2019 | SESE |
| K190264 | Viola | Meditime Co., Ltd. | Aug 15, 2019 | SESE |
| K190245 | PDS Barbed Suture, PDO MAXX Threads | Pdo Max, Inc. | Jun 4, 2019 | SESE |
| 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 | ETHICON, Inc. | Jan 10, 2019 | SESE |
| K172602 | Miracu | Feeltech Co., Ltd. | Nov 14, 2018 | SESE |
Top Applicants
- ETHICON, Inc. — 8 clearances
- Surgical Specialties Corp — 5 clearances
- Hans Biomed Corporation — 3 clearances
- Feeltech Co., Ltd. — 3 clearances
- Depuy Mitek — 3 clearances
