← Product Code [MAI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI) · K964013 # MITEK ABSORBABLE TOGGLE ANCHOR (K964013) _Mitek Products · MAI · Feb 24, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI/K964013 ## Device Facts - **Applicant:** Mitek Products - **Product Code:** [MAI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI.md) - **Decision Date:** Feb 24, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use SHOULDER 1. Rotator Cuff repair 2. Capsule shift/capsulo-labral reconstruction KNEE 1. Extra-capsular repairs and reattachment of: - medial collateral ligament - lateral collateral ligament - posterior oblique ligament and joint capsule to tibia - joint capsule closure to the anterior proximal tibia 2. Extra-capsular construction, ITB tenodesis 3. Patellar ligament and tendon avulsion repairs ANKLE 1. Achilles tendon repair/reconstruction ## Device Story Absorbable bone anchor for soft tissue-to-bone fixation; cylindrical/conical shape (0.44" x 0.11"); molded from Poly-lactiac (PLA). Used in orthopedic surgery (shoulder, knee, ankle) by surgeons to secure USP #2 sutures below bone surface. Device inserted into predrilled bone hole; toggle mechanism locks suture in place. Provides temporary fixation during tissue healing/rehabilitation. Benefits include secure attachment of ligaments/tendons to bone using absorbable material. ## Clinical Evidence Bench testing only. Pull tests performed in cadaver bone; average failure load of 32 pounds. ## Technological Characteristics Material: Poly-lactiac (PLA). Form factor: Cylindrical/conical anchor, 0.44" length x 0.11" diameter. Fixation principle: Toggle mechanism for suture locking in predrilled bone hole. ## Regulatory Identification Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - MITEK® STEALTH ANCHOR™ - MITEK® WEDGE ANCHOR ## 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} k964013 FEB 24 1997 # SUMMARY OF SAFETY AND EFFECTIVENESS ## MITEK® ABSORBABLE TOGGLE ANCHOR ### SUBMITTER NAME: Mitek Surgical Products, Inc. ADDRESS: 60 Glacier Drive, Westwood, MA 02090 TEL#: 617-461-9700 CONTACT: Edward F. Kent, Vice President, Regulatory Affairs DATE: October 4, 1996 ### NAME OF DEVICE CLASSIFICATION NAME: Staple, Fixation, Bone COMMON NAME: Appliance for reconstruction of bone to soft tissue. PROPRIETARY NAME: MITEK® ABSORBABLE TOGGLE ANCHOR PREDICATE DEVICE: MITEK® STEALTH ANCHOR™ MITEK® WEDGE ANCHOR ### DESCRIPTION OF THE DEVICE #### FUNCTION Fixation of USP #2 suture below bone surface using unique design, insertion techniques, and materials. #### DEVICE DESIGN The Mitek Absorbable Toggle Anchor is cylindrical/conical in shape with an overall length of 0.44" x 0.11" in diameter. #### MATERIALS USED The Mitek Absorbable Toggle Anchor is molded from Poly-lactiac (PLA). ### INTENDED USE #### SHOULDER 1. Rotator Cuff repair 2. Capsule shift/capsulo-labral reconstruction #### KNEE 1. Extra-capsular repairs and reattachment of: - medial collateral ligament - lateral collateral ligament - posterior oblique ligament and joint capsule to tibia - joint capsule closure to the anterior proximal tibia 2. Extra-capsular construction, ITB tenodesis 3. Patellar ligament and tendon avulsion repairs #### ANKLE 1. Achilles tendon repair/reconstruction 70 {1} COMPARISON TO PREDICATE DEVICE The Mitek Absorbable Toggle Anchor is similar to the Mitek Stealth and Wedge Anchor in materials and to all other Mitek Anchors in use and function, i.e., to "hold" tissue, with sutures that are locked into a predrilled bone hole, for a period of rehabilitation. DESCRIPTION OF NON CLINICAL TESTS Mitek Absorbable Toggle Anchor pull tests from cadaver bone provided an average failure load of 32 pounds. 71 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI/K964013](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI/K964013) **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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