QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM

K963200 · Wrightmedicaltechnologyinc · MBI · Oct 2, 1996 · Orthopedic

Device Facts

• Record ID: K963200
• Device Name: QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MBI · Orthopedic
• Decision Date: Oct 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The QUESTUS™ Polyester Suture Soft Tissue Anchor System is indicated for the following: - 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; - repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation; - repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament; - 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; - 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

QUESTUS™ Polyester Suture Soft Tissue Anchor System (7.5mm) is a single-use, sterile, preassembled kit; includes titanium alloy bone anchor, polyester suture, and disposable instrument driver. Device used by surgeons in clinical settings to secure soft tissue to bone via threaded anchor insertion. Output is mechanical fixation of soft tissue to bone. Benefits include stabilization of joint structures following ligament or tendon injury.

Clinical Evidence

Bench testing only. Tested per Draft Guidance Document for Testing Bone Anchor Devices (April 1, 1993). Results indicate 7.5mm anchor performance meets or exceeds 5.0mm predicate.

Technological Characteristics

Titanium alloy bone anchor; polyester suture; disposable instrument driver. Threaded fixation mechanism. Sterile, single-use kit.

Indications for Use

Indicated for patients requiring soft tissue-to-bone fixation for repair of instability or ligament/tendon tears in shoulder, elbow, hand/wrist, knee, and foot/ankle joints.

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

• QUESTUS™ Polyester Suture Soft Tissue Anchor System

Submission Summary (Full Text)

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SEP-30-96 14:13 FROM:WRIGHT MEDICAL CR AFFAIRS
PAGE 4/7
OCT - 2 1996
K963200

WRIGHT
MEDICAL TECHNOLOGY, INC.
5677 AIRLINE ROAD
ARLINGTON, TN 38002
901-867-9971

510(k) Summary

Contact Person: Cristie Manuel
Date Prepared: September 30, 1996

Trade/Proprietary Name: QUESTUS™ Polyester Suture Soft Tissue Anchor System, Size 7.5mm
Common Name: Fastener, fixation, nondegradable, soft tissue
Product Classification: Class II
Predicate Device: QUESTUS™ Polyester Suture Soft Tissue Anchor System

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 QUESTUS™ Polyester Suture Soft Tissue Anchor System, size 7.5mm, is a single use, sterile, preassembled kit consisting of a bone anchor, a suture, and a disposable instrument driver, and is an additional size offering to the QUESTUS™ Polyester Suture Soft Tissue Anchor System. The anchor is manufactured from titanium alloy and threaded into bone. Soft tissue is secured to the implant site with suture.

The QUESTUS™ Polyester Suture Soft Tissue Anchor System is indicated for the following:
- 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;
- repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation;
- repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
- 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;
- 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
The 7.5mm QUESTUS™ Polyester Suture Soft Tissue Anchor System was tested according to Draft Guidance Document for Testing Bone Anchor Devices, April 1, 1993. The conclusion from this test is that the 7.5mm anchor can be expected to meet or exceed the in vivo performance of the 5.0mm anchor.