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Cytoplast PTFE Suture

FDA 510(k)

Class II (US FDA 510(k))

510(k) K072076

by Osteogenics Biomedical, Inc.

Identifiers

510(k) Number
K072076 FDA 510(k)
FDA Product Code
NBY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.5035 FDA 510(k)
Regulation Number
878.5035 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cytoplast PTFE Suture is a Surgical, Nonabsorbable, Expanded Polytetrafluoroethylene (PTFE) Suture, designed for soft tissue approximation and closure. Its monofilament construction provides a smooth, atraumatic passage through tissue while minimizing bacterial wicking into the surgical site. The expanded PTFE material offers strength and flexibility, making it suitable for delicate procedures where a soft, pliable suture is required.

This suture is supplied in sterile, single-use packaging for surgical applications in general and plastic surgery. It is classified as a Class II medical device under FDA regulations (21 CFR 878.5035) and holds an FDA 510(k) clearance (K072076) for use in soft tissue closure. Multiple sizes and reference codes are available, as listed in the registration database, ensuring compatibility with various clinical needs. Storage should adhere to manufacturer guidelines to maintain sterility and integrity.

Frequently asked questions

What is the Cytoplast PTFE Suture designed for?

The Cytoplast PTFE Suture is specifically designed for soft tissue approximation and closure in surgical procedures. Its expanded polytetrafluoroethylene (PTFE) material provides a smooth, atraumatic passage through tissue, reducing trauma and minimizing bacterial wicking into the surgical site. This makes it ideal for delicate surgeries where a flexible, strong suture is required, particularly in general and plastic surgery.

How is the Cytoplast PTFE Suture supplied, and is it reusable?

The Cytoplast PTFE Suture is supplied in sterile, single-use packaging, ensuring compliance with surgical standards for infection control. Due to its sterile packaging and nonabsorbable nature, it is intended for one-time use only. Reuse is not recommended as it could compromise sterility and integrity, potentially leading to adverse clinical outcomes.

What sizes and reference codes are available for the Cytoplast PTFE Suture?

Multiple sizes and reference codes are available for the Cytoplast PTFE Suture, as listed in the registration database. These variations ensure compatibility with a wide range of clinical needs, allowing clinicians to select the appropriate size for their specific surgical requirements. The exact reference codes can be found in the manufacturer’s product catalog or registration records.

How should the Cytoplast PTFE Suture be stored to maintain sterility?

To maintain sterility and integrity, the Cytoplast PTFE Suture should be stored according to the manufacturer’s guidelines. This typically includes keeping the sterile packaging unopened and sealed until use, storing in a clean, dry environment protected from extreme temperatures, moisture, and direct sunlight. Proper storage ensures the suture remains effective and safe for surgical use.

Is the Cytoplast PTFE Suture suitable for both general and plastic surgery?

Yes, the Cytoplast PTFE Suture is FDA-cleared for use in soft tissue closure within both general and plastic surgery. Its monofilament construction and PTFE material provide the flexibility and strength needed for delicate procedures, making it versatile for various surgical applications in these specialties.

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: Cytoplast™ Osteogenics - Hager & Meisinger, Cytoplast™ Non-Absorbable PTFE Sutures - Osteogenics Biomedical, Cytoplast™ TXT-200 Non-Resorbable High-Density PTFE Membrane, PDF CYTOPLAST PTFE Suture - osteogenics.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Osteogenics Biomedical, Inc.

Sources (1)

  • FDA 510(k) K072076 24 fields · synced Oct 1, 2026