Who is the manufacturer of MULTITAK SS SUTURE SYSTEM?

Bonutti Research filed the 510(k) submission for MULTITAK SS SUTURE SYSTEM (K964324).

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 (K934183); GII Anchor System (K953877); Mini QuickAnchor (K930892); Mini QuickAnchor (K904436).

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

K964324 · Bonutti Research · MBI · Jan 10, 1997 · Orthopedic

Device Facts

Record ID	K964324
Device Name	MULTITAK SS SUTURE SYSTEM
Applicant	Bonutti Research
Product Code	MBI · Orthopedic
Decision Date	Jan 10, 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, Wrist and Hand - Ulnar or radial collateral ligament reconstructions - Tennis elbow repair - Biceps tendon reattachment Knee - Extra-capsular repairs: - Medial collateral ligament - Lateral collateral ligament

Device Story

Tubular soft tissue 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 repairs. Facilitates fixation of ligaments and tendons to bone; enables tissue reattachment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Tubular anchor; braided polyester suture (USP 2-0 to 2); metallic bone fixation fastener per 21 CFR 888.3040. Includes introduction device for delivery into predrilled bone holes.

Indications for Use

Indicated for soft tissue to bone suture fixation in shoulder (rotator cuff, biceps tenodesis), foot/ankle (lateral instability), elbow/wrist/hand (collateral ligament, tennis elbow, biceps tendon), and knee (medial/lateral collateral ligament) procedures.

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 (K934183)
GII Anchor System (K953877)
Mini QuickAnchor (K930892)
Mini QuickAnchor (K904436)

Related Devices

K971144 — MULTITAK SS SUTURE SYSTEM · Bonutti Research · Jun 25, 1997
K964532 — MULTITAK SS SUTURE SYSTEM · Bonutti Research · Feb 3, 1997
K020159 — SMITH & NEPHEW TWINFIX TI QUICK T · Smith & Nephew, Inc. · Mar 26, 2002
K081511 — 2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S · Smith & Nephew, Inc. · Aug 26, 2008
K232742 — Arthrex FiberTak Suture Anchor · Arthrex, Inc. · Nov 3, 2023

Submission Summary (Full Text)

{0} NUTTI RESEARCH, INC. 1<964324 # 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** October 28, 1996 - **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, manufactured by Bonutti Research, K934183. - GII Anchor System, manufactured by Mitek Surgical Products, Inc., K953877. - Mini QuickAnchor, manufactured by Mitek Surgical Products, Inc., K930892 and K904436. JAN 10 1997 {1} 17 - 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. - 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, Wrist and Hand - Ulnar or radial collateral ligament reconstructions - Tennis elbow repair - Biceps tendon reattachment Knee - Extra-capsular repairs: - Medial collateral ligament - Lateral collateral ligament - Performance Data The nature of device changes do not necessitate performance data testing.