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Cytoplast Suture; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC

FDA 510(k)

Class II (US FDA 510(k))

510(k) K003028

by Osteogenics Biomedical, Inc.

Identifiers

510(k) Number
K003028 FDA 510(k)
FDA Product Code
NBY FDA 510(k)
Models / Variants
Cytoplast Suture FDA 510(k)
Cs-0318, Cs-0416, Cs-0418, Cs-0513, Cs-0513pc, Cs-0516hc 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)

Cytoplast Suture is a surgical, nonabsorbable, expanded polytetrafluoroethylene suture. It is classified as a suture device under FDA regulation number 878.5035 and has received FDA 510(k) clearance under K003028 as substantially equivalent to a predicate device.

The device is supplied in multiple model numbers including CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, and CS-0516HC. It is intended for use in general and plastic surgery procedures. The suture is nonabsorbable and designed for soft tissue approximation where a monofilament construction is desired.

Frequently asked questions

What is Cytoplast Suture used for?

Cytoplast Suture is intended for use in general and plastic surgery procedures to approximate soft tissue where a nonabsorbable, monofilament construction is desired, providing long-term wound support.

How is Cytoplast Suture supplied and what models are available?

Cytoplast Suture is supplied in multiple model numbers: CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, and CS-0516HC, each representing different sizes or configurations of the expanded polytetrafluoroethylene suture material.

Is Cytoplast Suture absorbable or nonabsorbable?

Cytoplast Suture is nonabsorbable, meaning it is not designed to break down or be absorbed by the body over time, making it suitable for applications requiring permanent tissue support.

What material is Cytoplast Suture made from?

Cytoplast Suture is made from expanded polytetrafluoroethylene (ePTFE), a biocompatible, inert fluoropolymer known for its smooth monofilament structure and resistance to tissue reaction.

What regulatory pathway was used for Cytoplast Suture?

Cytoplast Suture received FDA 510(k) clearance under K003028 as substantially equivalent to a predicate device, classified under FDA regulation number 878.5035 as a suture 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: Cytoplast™ Osteogenics - Hager & Meisinger, Cytoplast™ Non-Absorbable PTFE Sutures - Osteogenics Biomedical, Cytoplast Suture; Cs-0318, Cs-0416, Cs-0418, Cs-0513, Cs-0513pc, Cs ..., Cytoplast Suture; Cs-0318, Cs-0416, Cs-0418, Cs-0513, Cs-0513pc, Cs ...

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) K003028 24 fields · synced Sep 25, 2026