Blue Orthocord Suture
FDA 510(k)Class II (US FDA 510(k))
by Depuy Mitek
Identifiers
- 510(k) Number
- K043298 FDA 510(k)
- FDA Product Code
- NEW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4840 FDA 510(k)
- Regulation Number
- 878.4840 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Blue Orthocord Suture is a synthetic, sterile, braided composite suture composed of dyed (D&C Blue #6) absorbable polydioxanone (PDS) and un-dyed non-absorbable polyethylene, coated with a copolymer of 90% caprolactone and 10% glycolide. It is designed for soft tissue approximation and ligation during orthopedic and general surgical procedures.
The suture is supplied in sterile form and is intended for single use. It is FDA 510(k) cleared with the product code NEW and is classified as a Class II device. The device is available in various sizes and is used in clinical settings by surgeons for soft tissue repair.
Frequently asked questions
What is Blue Orthocord Suture composed of?
Blue Orthocord Suture is a synthetic, braided composite made of dyed absorbable polydioxanone (PDS) and un-dyed non-absorbable polyethylene, coated with a copolymer of 90% caprolactone and 10% glycolide.
What is Blue Orthocord Suture used for?
Blue Orthocord Suture is designed for soft tissue approximation and ligation during orthopedic and general surgical procedures.
Is Blue Orthocord Suture single-use or reusable?
Blue Orthocord Suture is supplied in sterile form and is intended for single use only.
What is the regulatory status of Blue Orthocord Suture?
Blue Orthocord Suture is FDA 510(k) cleared with the product code NEW and is classified as a Class II device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ORTHOCORD™ High Strength Suture | DePuy Synthes, DEPUY MITEK: 223113 Geosurgical, DYNACORD Suture | Products | DePuy Synthes, BLUE ORTHOCORD SUTURE (K043298) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K043298 | Class II | Active |
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Manufacturer
- Manufacturer
- Depuy Mitek
Sources (1)
- FDA 510(k) K043298 24 fields · synced Sep 26, 2026