← Product Code [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI) · K964532 # MULTITAK SS SUTURE SYSTEM (K964532) _Bonutti Research · MBI · Feb 3, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K964532 ## Device Facts - **Applicant:** Bonutti Research - **Product Code:** [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI.md) - **Decision Date:** Feb 3, 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 - 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). ## 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 (Bonutti Research) ## 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} 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. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K964532](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K964532) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com