NEWFDA Class 2 · 21 CFR 878.4840 · implantable
Suture, Surgical, Absorbable, Polydioxanone
Device family · General, Plastic Surgery
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
89
Manufacturers
11
Flagged signals
12
Adverse-event reports
14,142
Code matrix
| FDA product code | NEW |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4840 |
| GMDN | — (crosswalk pending) |
| Implantable | Yes |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2015 | 52 | 135.3 | 6,797 |
| Other | 2014 | 48 | 124.9 | 5,775 |
| Other | 2013 | 25 | 65.0 | 1,513 |
| Other | 2011 | 18 | 46.8 | 762 |
| Other | 2010 | 17 | 44.2 | 676 |
| Other | 2012 | 9 | 23.4 | 171 |
| Other | 2013 | 7 | 18.2 | 97 |
| Other | 2014 | 5 | 13.0 | 44 |
| 2016 | 4 | 8.6 | 20 | |
| Other | 2010 | 3 | 7.8 | 12 |
| Other | 2009 | 3 | 7.8 | 12 |
| Injury | 2024 | 8 | 2.1 | 6 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 14,142 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Ethicon, Inc. | 35 | 2025 | — |
| DePuy Mitek | 3 | 2008 | — |
| Hyundae Meditech Co., Ltd. | 2 | 2024 | — |
| Suturion AB | 2 | 2025 | — |
| Demetech Corporation | 2 | 2019 | — |
| Coloplast A/S | 1 | 2012 | — |
| Dongwon Medical Co., Ltd. | 1 | 2016 | — |
| Foosin Medical Supplies Inc., Ltd. | 1 | 2020 | — |
| Internacional Farmaceutica, S.A. de C.V. | 1 | 2004 | — |
| Genzyme Biosurgery | 1 | 2003 | — |
| MEDITIME CO., LTD. | 1 | 2019 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture · ETHICON, Inc.510(k) · 2025-11-12
Miracu Polydioxanone (PDO) Suture and Needle (MONO) · Feeltech Co., Ltd.510(k) · 2025-10-20
V-soft Line Barbed Surgical Suture (Various) · Feeltech Co., Ltd.510(k) · 2025-10-15
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.510(k) · 2025-09-23
Suture-TOOL System · Suturion AB510(k) · 2025-04-28
Suture-TOOL System · Suturion AB510(k) · 2025-01-22
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.510(k) · 2024-09-27
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.510(k) · 2024-04-25
Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150) · Hyundae Meditech Co., Ltd.510(k) · 2024-03-27
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 Corporation510(k) · 2023-03-07
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture · ETHICON, Inc.510(k) · 2022-02-22
PDO Max Suture with Dual Needle · Pdo Max, Inc.510(k) · 2021-12-17
WEGO-PDO Barbed Suture · Foosin Medical Supplies Inc., Ltd.510(k) · 2020-10-20
MINT Product Family · Hans Biomed Corporation510(k) · 2020-09-09
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device · ETHICON, Inc.510(k) · 2020-03-25
DemeDIOX Barbed Absorbable Surgical Suture · Demetech Corporation510(k) · 2019-11-07
Viola · Meditime Co., Ltd.510(k) · 2019-08-15
PDS Barbed Suture, PDO MAXX Threads · Pdo Max, Inc.510(k) · 2019-06-04
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.510(k) · 2019-01-10
Miracu · Feeltech Co., Ltd.510(k) · 2018-11-14
DemeTECH DemeDIOX absorbable surgical suture · Demetech Corporation510(k) · 2018-08-27
Omega VL · Ov World Co., Ltd.510(k) · 2018-03-02
RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed · Myco Medical510(k) · 2017-03-02
Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, · Y. Jacobs Medical, Inc.510(k) · 2016-11-23
DW-1C · Dongwon Medical Co., Ltd.510(k) · 2016-11-22
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.