ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM

K964786 · Wrightmedicaltechnologyinc · MBI · Feb 6, 1997 · Orthopedic

Device Facts

• Record ID: K964786
• Device Name: ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MBI · Orthopedic
• Decision Date: Feb 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• 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.

Indications for Use

Indicated for patients requiring soft tissue-to-bone fixation for repair of instability or tears in shoulder, elbow, hand/wrist, knee, and foot/ankle, and for female urinary incontinence due to urethral hypermobility.

Regulatory Classification

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)

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K964786


# 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.