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Tephaflex Braided Suture

FDA 510(k)

Class II (US FDA 510(k))

510(k) K132348

by Tepha, Inc.

Identifiers

510(k) Number
K132348 FDA 510(k)
FDA Product Code
NWJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4494 FDA 510(k)
Regulation Number
878.4494 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Tephaflex Braided Suture is a braided absorbable suture constructed from poly-4-hydroxybutyrate, a recombinant biopolymer. It is classified as a suture, absorbable, braided under FDA nomenclature and designed for soft tissue approximation and ligation in general and plastic surgery applications. The device retains tensile strength while offering improved flexibility compared to traditional absorbable sutures. Its braided structure enhances knot security and handling characteristics during surgical procedures.

This suture is supplied in a sterile, single-use configuration and is intended for general soft tissue approximation and ligation only, excluding cardiovascular, neurological, microsurgical, or ophthalmic applications. It is regulated under FDA 510(k) clearance (K132348) as a Class II device (NWJ product code) and must be stored according to manufacturer instructions to maintain sterility. The device is not intended for MRI environments unless explicitly labeled for such use, though no MRI compatibility data is provided in the specifications.

Frequently asked questions

What is the Tephaflex Braided Suture used for?

The Tephaflex Braided Suture is designed specifically for soft tissue approximation and ligation in general and plastic surgery applications. Its braided structure and recombinant poly-4-hydroxybutyrate composition provide enhanced flexibility and knot security compared to traditional absorbable sutures, making it suitable for procedures requiring precise handling and secure closure.

How is the Tephaflex Braided Suture supplied and what does sterility mean in this context?

The Tephaflex Braided Suture is supplied in a sterile, single-use configuration. Sterility in this context means the suture has undergone validated processes to eliminate or reduce microorganisms to levels that ensure safe use in surgical settings, preventing post-operative infections. It is critical to maintain sterility by following the manufacturer’s storage instructions to preserve its integrity.

Is the Tephaflex Braided Suture reusable or intended for single-use?

The Tephaflex Braided Suture is explicitly intended for single-use only. This designation ensures patient safety by preventing contamination from repeated use, which could introduce pathogens or compromise the suture’s structural integrity. Reusing absorbable sutures is not recommended due to potential degradation and loss of tensile strength over time.

What storage conditions are required to maintain sterility?

To maintain sterility, the Tephaflex Braided Suture must be stored according to the manufacturer’s instructions, which typically include keeping it in its original, unopened packaging, protected from moisture, heat, and direct light. Avoiding exposure to contaminants and adhering to expiration dates ensures the suture remains effective and safe for surgical use.

Can the Tephaflex Braided Suture be used in MRI environments?

The Tephaflex Braided Suture is not explicitly labeled for use in MRI environments, and no MRI compatibility data is provided. If MRI imaging is required post-surgery, clinicians should consult the manufacturer for guidance or use alternative sutures specifically designed for MRI-safe procedures to avoid potential risks such as heating or imaging artifacts.

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: TephaFLEX Absorbable Monofilament Suture - Medical XPRT, PDF JUL 1 i 2008 - Food and Drug Administration, TEPHAFLEX ABSORBABLE SUTURE (K081099) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Tepha, Inc.

Sources (1)

  • FDA 510(k) K132348 24 fields · synced Oct 1, 2026