I-Thread
i-Thread is identified in the filing as a sterile, single-use absorbable polydioxanone suture with a needle. The described needle is cannula-type, straight and hollow. The suture is…
i-Thread is identified in the filing as a sterile, single-use absorbable polydioxanone suture with a needle. The described needle is cannula-type, straight and hollow.
The suture is intended for soft tissue approximation where absorbable suture is appropriate, and the filing limits its use to dermatological applications.
Listed Item
i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2.
Construction
The device description lists a needle cap, hub and sponge with the PDO suture. It describes bidirectional barbs along the monofilament length.
Who Else Makes It
Concentrated in Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Hyundae Meditech Co., Ltd., South Korea |
|---|---|
| FDA product code | NEW |
| Device type | Suture, Surgical, Absorbable, Polydioxanone |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4840 |
| Establishment | Manufacturer |
| 510(k) | K242571 |
| Record published | 2025-06-17 |
| Record revised | 2025-07-15 (version 2) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 59 to 77 °F |
| Packaging | Pouch of 10, box of 50 |
| Sizes | Length 90 to 185 mm |
| Distribution end date | 2025-07-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FCHL19100E160 | Length 160 mm | In distribution |
| FCL19100E160 | Length 160 mm | In distribution |
| FCRL18100C185 | Length 185 mm | In distribution |
| FCRL1970E162 | Length 162 mm | In distribution |
| FCL18100C160 | Length 120 mm | In distribution |
| FCHL1960E90 | Length 90 mm | In distribution |
| FCL19100E160 | Length 160 mm | Withdrawn |
| FCL18100C160 | Length 160 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeDIOX | Demetech Corp. | 994 |
| Monoplus | B Braun Surgical SA | 697 |
| PDS | Ethicon, Inc. | 430 |
| Wego-PDO Absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 180 |
| Stratafix | Ethicon, Inc. | 172 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 74 |
| PDO Max Threads | Max Pdo Inc | 64 |
| Assufil Monofilamento | Assut Europe | 50 |
| LES Encres | Meditime Co., Ltd. | 42 |
| DemeDIOX Barbed | Demetech Corp. | 40 |
| Viola | Meditime Co., Ltd. | 36 |
| Stratafix Spiral | Surgical Specialties México, S. de R.L. de C.V. | 34 |
Showing 12 of 292. All products under Suture, Surgical, Absorbable, Polydioxanone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242571 | 2024-09-27 |
| K240389 | 2024-03-27 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N18331 | 1986-06-06 | PDS SUTURE (DYED) | Ethicon, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.