Who is the manufacturer of MULTITAK SS SUTURE SYSTEM?

Bonutti Research filed the 510(k) submission for MULTITAK SS SUTURE SYSTEM (K964532).

What is the FDA product code for MULTITAK SS SUTURE SYSTEM?

MBI. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for MULTITAK SS SUTURE SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MULTITAK SS SUTURE SYSTEM?

Multitak SS Suture System (Bonutti Research).

Who can help prepare an FDA 510(k) submission like MULTITAK SS SUTURE SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MULTITAK SS SUTURE SYSTEM

K964532 · Bonutti Research · MBI · Feb 3, 1997 · Orthopedic

Device Facts

Record ID	K964532
Device Name	MULTITAK SS SUTURE SYSTEM
Applicant	Bonutti Research
Product Code	MBI · Orthopedic
Decision Date	Feb 3, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The devices are intended for soft tissue to bone suture fixation for the following indications: Shoulder - Rotator cuff tear repairs - Biceps tenodesis Foot and Ankle - Lateral instability repairs/reconstructions Elbow - Ulnar or radial collateral ligament reconstructions - Tennis elbow repair - Biceps tendon reattachment Knee - Extra-capsular repairs: - Medial collateral ligament - Lateral collateral ligament

Device Story

Multitak Suture System consists of tubular bone anchor preassembled with USP size 2-0 to 2 braided polyester suture. Introduction device delivers anchor into predrilled bone hole; sutures secure soft tissue to bone. Used by surgeons in clinical settings for orthopedic soft tissue fixation. Device provides mechanical attachment of ligaments/tendons to bone to facilitate healing. Benefit: secure fixation for various orthopedic repairs.

Clinical Evidence

Bench testing only. Pullout tension testing performed in cadaver bone comparing Multitak Suture System to predicate device. Results showed performance equal to or better than predicate.

Technological Characteristics

Tubular bone anchor; braided polyester suture (USP 2-0 to 2); metallic bone fixation fastener (21 CFR 888.3040).

Indications for Use

Indicated for soft tissue to bone suture fixation in shoulder (rotator cuff repair, biceps tenodesis), foot/ankle (lateral instability repair/reconstruction), elbow (ulnar/radial collateral ligament reconstruction, tennis elbow repair, biceps tendon reattachment), and knee (medial/lateral collateral ligament extra-capsular repairs).

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

Multitak SS Suture System (Bonutti Research)

Related Devices

K973015 — MULTITAK SS SUTURE SYSTEM · Bonutti Research · Oct 9, 1997
K971144 — MULTITAK SS SUTURE SYSTEM · Bonutti Research · Jun 25, 1997
K964324 — MULTITAK SS SUTURE SYSTEM · Bonutti Research · Jan 10, 1997
K151342 — Arthrex SwiveLock Anchors · Arthrex, Inc. · Mar 24, 2016
K020159 — SMITH & NEPHEW TWINFIX TI QUICK T · Smith & Nephew, Inc. · Mar 26, 2002

Submission Summary (Full Text)

{0} 01/13/1995 02:48 2173473384 JOINT ACTIVE SYSTEMS PAGE 02 # BONUTTI RESEARCH, INC K964532 FEB - 3 1997 ## Summary of Safety and Effectiveness Multitak Suture System™ - **Submitted by** Bonutti Research 1303 Evergreen Ave. Effingham, IL 62401 - **Prepared by** Lynnette Whitaker Director Regulatory Affairs/Quality Assurance - **Date** January 29, 1997 - **Trade Name** *Multitak* Suture System - **Common Name** Soft Tissue Anchor - **Classification Name** 21 CFR 888.3040, Smooth or Threaded Metallic Bone Fixation Fastener - **Predicate Devices** *Multitak* SS Suture System, marketed by Bonutti Research. - **Device Description** The anchor is tubular in shape and is preassembled threaded with USP size 2-0 through 2 braided polyester suture. An Introduction Device holds the anchor and delivers it into the bone through a predrilled hole. The sutures can then be used to secure the soft tissue to the bone. {1} 01/13/1985 02:48 2173473384 JOINT ACTIVE SYSTEMS PAGE 03 - Intended Use The devices are intended for soft tissue to bone suture fixation for the following indications: Shoulder - Rotator cuff tear repairs - Biceps tenodesis Foot and Ankle - Lateral instability repairs/reconstructions Elbow - Ulnar or radial collateral ligament reconstructions - Tennis elbow repair - Biceps tendon reattachment Knee - Extra-capsular repairs: - Medial collateral ligament - Lateral collateral ligament - Performance Data Pullout tension testing of the Multitak Suture System was performed in cadaver bone and compared to similar testing of the predicate device. Results demonstrated that the performance of the Multitak Suture System was equal to or better than the performance of the predicate device.