← Product Code [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI) · K962397 # STATAK SOFT TISSUE ATTACHMENT DEVICE (K962397) _Zimmer, Inc. · MBI · Aug 27, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K962397 ## Device Facts - **Applicant:** Zimmer, Inc. - **Product Code:** [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI.md) - **Decision Date:** Aug 27, 1996 - **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 - Bankart lesion repairs - SLAP lesion repairs - Acromio-clavicular separation repairs - Rotator cuff tear repairs - Capsular shift or capsulolabral reconstructions - Biceps tenodesis - Deltoid repairs Foot and Ankle - Medial or lateral instability repairs/reconstructions - Achilles tendon repairs/reconstructions - Midfoot reconstructions - Hallus valgus reconstructions Elbow, Wrist, and Hand - Scapholunate ligament reconstructions - Ulnar or radial collateral ligament reconstructions - Tennis elbow repair - Biceps tendon reattachment Knee - Extra-capsular repairs: -- Medial collateral ligament -- Lateral collateral ligament -- Posterior oblique ligament - Iliotibial band tenodesis - Patellar tendon repairs ## Device Story Statak Soft Tissue Attachment Device; 2.5 mm diameter, self-tapping, self-drilling, fully threaded bone anchor. Features attached double-strand, braided, nonabsorbable Size No. 2-0 suture. Delivered via disposable driver compatible with powered handpieces. Used by surgeons in clinical settings to secure soft tissue to bone. Driver delivers anchor into bone; removed to leave suture strands for tissue fixation. Benefits include secure attachment of ligaments/tendons to bone during orthopedic reconstructive procedures. ## Clinical Evidence Bench testing only. Tension loading of suture in cadaveric hand bones compared to suture-only tenodesis procedure. Results demonstrated performance equivalent to suture-only tenodesis. ## Technological Characteristics 2.5 mm diameter, self-tapping, self-drilling, fully threaded metallic bone anchor. Includes attached double-strand, braided, nonabsorbable Size No. 2-0 suture. Disposable driver interface for powered handpiece delivery. ## 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 - Statak® Soft Tissue Attachment Device ([K926384](/device/K926384.md)) - GII Anchor System ([K953877](/device/K953877.md)) - Mini Anchor ([K930892](/device/K930892.md)) - Mini Anchor ([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} Zimmer AUG 27 1996 PO. Box 708 Warsaw, IN 46581-0708 219 267-6131 K962397 # Summary of Safety and Effectiveness ## Statak Soft Tissue Attachment Device - **Submitted by:** Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 - **Prepared by:** Lynnette Whitaker Manager Regulatory Affairs - **Date:** June 17, 1996 - **Trade Name:** *Statak®* Soft Tissue Attachment Device - **Common Name:** Soft Tissue Anchor - **Classification Name:** 21 CFR 888.3040, Smooth or Threaded Metallic Bone Fixation Fastener - **Predicate Devices:** - *Statak®* Soft Tissue Attachment Device, K926384 - GII Anchor System, manufactured by Mitek Surgical Products, Inc., K953877 - Mini Anchor, manufactured by Mitek Surgical Products, Inc., K930892 and K904436 1 46 A Bristol-Myers Squibb Company {1} - Device Description: The Statak Soft Tissue Attachment Device anchor has a diameter of 2.5 mm, is self-tapping, self-drilling, and fully threaded. A double strand, braided, nonabsorbable Size No. 2-0 suture is attached to an eyelet at the end of the anchor. A disposable driver which can be attached to a powered handpiece holds the excess suture and delivers the anchor directly into the bone. When the driver is removed, the suture strands are left emerging from the bone. The strands are then 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 - Bankart lesion repairs - SLAP lesion repairs - Acromio-clavicular separation repairs - Rotator cuff tear repairs - Capsular shift or capsulolabral reconstructions - Biceps tenodesis - Deltoid repairs Foot and Ankle - Medial or lateral instability repairs/reconstructions - Achilles tendon repairs/reconstructions - Midfoot reconstructions - Hallus valgus reconstructions Elbow, Wrist, and Hand - Scapholunate ligament reconstructions - Ulnar or radial collateral ligament reconstructions - Tennis elbow repair - Biceps tendon reattachment Knee - Extra-capsular repairs: 47 {2} -- Medial collateral ligament -- Lateral collateral ligament -- Posterior oblique ligament - Iliotibial band tenodesis - Patellar tendon repairs - **Performance Data:** The *Statak* Soft Tissue Attachment Device was tested by tension loading the suture in the hand bones of cadaver specimens, with the results compared to a suture-only tenodesis procedure in similar bone. The *Statak* Soft Tissue Attachment Device performed as well as the suture-only tenodesis procedure. RA06601K.510 48 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K962397](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K962397) **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