← Product Code [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI) · K964786 # ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM (K964786) _Wrightmedicaltechnologyinc · MBI · Feb 6, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K964786 ## Device Facts - **Applicant:** Wrightmedicaltechnologyinc - **Product Code:** [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI.md) - **Decision Date:** Feb 6, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The ANCHORLOK™ RL Soft Tissue Anchor System is intended for use: - In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction; - In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation; - In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament; - Female urinary incontinence due to urethral hypermobility; - In the repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis; - In the repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments. ## Device Story Single-use, sterile kit; includes titanium alloy bone anchor, disposable wire leader, and protective sleeve. Used by surgeons in clinical settings for soft tissue-to-bone fixation. Anchor implanted into bone to secure tendons or ligaments; provides mechanical fixation to facilitate healing of instability or tears. Benefits include restoration of joint stability and treatment of urinary incontinence. ## Clinical Evidence Bench testing only. In vitro pullout strength testing in the pubis performed to compare subject device against Statak™ predicate. ## Technological Characteristics Material: Titanium alloy. Components: Bone anchor, disposable wire leader, disposable protective sleeve. Single-use, sterile kit. ## 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 - ANCHORLOK™ RL Soft Tissue Anchor System (manufacturer: Wright Medical Technology, Inc.) - Statak™ Soft Tissue Attachment Device (manufacturer: Zimmer) ## 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} K964786 ![img-0.jpeg](img-0.jpeg) # WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE ROAD ARLINGTON, TN 38002 901-867-9971 FEB - 6 1997 # 510(k) Summary Contact Person: Cristie Manuel Date Prepared: January 30, 1997 Trade/Proprietary Name: ANCHORLOK™ RL Soft Tissue Anchor System Classification Name: Fastener, fixation, nondegradable, soft tissue Predicate Device: ANCHORLOK™ RL Soft Tissue Anchor System manufactured for Wright Medical Technology, Inc., and the Statak™ Soft Tissue Attachment Device manufactured by Zimmer. This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92. Description/Intended Use The ANCHORLOK™ RL Soft Tissue Anchor System is a single use, sterile kit consisting of a bone anchor with a disposable wire leader and disposable protective sleeve. The anchor is manufactured from titanium alloy. The ANCHORLOK™ RL Soft Tissue Anchor System is intended for use: - In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction; - In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation; - In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament; - Female urinary incontinence due to urethral hypermobility; - In the repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis; - In the repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments. Testing Summary Conclusion: In vitro pullout strength testing in the pubis indicates the ANCHORLOK™ RL Anchor can be expected to meet or exceed the pullout strength of the predicate Statak™ anchor. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K964786](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K964786) **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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