← Product Code [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI) · K964324 # MULTITAK SS SUTURE SYSTEM (K964324) _Bonutti Research · MBI · Jan 10, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K964324 ## Device Facts - **Applicant:** Bonutti Research - **Product Code:** [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI.md) - **Decision Date:** Jan 10, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## Regulatory 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](/device/K934183.md)) - GII Anchor System ([K953877](/device/K953877.md)) - Mini QuickAnchor ([K930892](/device/K930892.md)) - Mini QuickAnchor ([K904436](/device/K904436.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K964324](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K964324) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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