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Multitak SS Suture System

by Bonutti Research 510(k)

Active United States

510(k) K964324

Overview

The Multitak SS Suture System is a Fastener, Fixation, Nondegradable, Soft Tissue device, classified under the MBI product code. It is designed for soft tissue approximation and fixation, utilizing stainless steel components to secure tissues together in surgical procedures.

This system is supplied as a sterile, single-use device and is intended for use in orthopedic and soft tissue surgical settings. It has received FDA 510(k) clearance under the Traditional review pathway, with the predicate device serving as a benchmark for performance equivalence. The device is regulated as Class II under Special Controls for soft tissue fixation.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK964324 Date10 Jan 1997ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MBI
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What types of surgical procedures is the Multitak SS Suture System intended for, and why is it specifically designed for soft tissue fixation?

    The Multitak SS Suture System is designed for soft tissue approximation and fixation in surgical procedures, particularly within orthopedic and soft tissue settings. It uses stainless steel components to securely hold tissues together, making it ideal for procedures requiring durable, non-degradable fixation where traditional sutures may not provide sufficient strength or stability.

  • Is the Multitak SS Suture System reusable, or is it meant for single-use only? How does this affect its sterility?

    The Multitak SS Suture System is supplied as a sterile, single-use device, meaning it is intended for one-time use only. This design ensures sterility is maintained throughout its intended use, reducing the risk of infection or contamination from reuse, which is critical in surgical settings where cleanliness and safety are paramount.

  • How is the regulatory pathway for the Multitak SS Suture System defined, and what does this mean for its use in clinical settings?

    The Multitak SS Suture System received FDA 510(k) clearance under the Traditional review pathway, meaning its safety and performance were compared to a predicate device (a previously approved benchmark) to demonstrate substantial equivalence. This classification as a Class II device under Special Controls for soft tissue fixation ensures it meets stringent regulatory standards for soft tissue fixation, providing clinicians with confidence in its reliability and compliance with medical device regulations.

  • What materials are used in the Multitak SS Suture System, and why is this important for its intended use?

    The Multitak SS Suture System is made of stainless steel components, a non-degradable material chosen for its durability and strength in securing soft tissues. This material choice is particularly important for procedures requiring long-term fixation, as stainless steel resists corrosion and maintains structural integrity over time, reducing the risk of failure or tissue irritation.