QUESTLOCK ACL FIXATOR

K954683 · Wrightmedicaltechnologyinc · MBI · Apr 23, 1996 · Orthopedic

Device Facts

• Record ID: K954683
• Device Name: QUESTLOCK ACL FIXATOR
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MBI · Orthopedic
• Decision Date: Apr 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The QuestLock ACL Fixator is intended to provide a means for firmly securing a bone-Patellar Tendon-bone graft during reconstruction of an Anterior Cruciate Ligament (ACL).

Device Story

QuestLock ACL Fixator; titanium alloy bone fixation device. Used during ACL reconstruction to secure bone-Patellar Tendon-bone grafts. Operated by orthopedic surgeons in clinical/OR settings. Provides mechanical graft stability. Benefits patient by ensuring secure graft attachment during ligament healing.

Clinical Evidence

Bench testing only; pull-out strength testing performed to demonstrate mechanical performance.

Technological Characteristics

Titanium alloy bone fixation device; mechanical staple/fixator form factor.

Indications for Use

Indicated for patients undergoing Anterior Cruciate Ligament (ACL) reconstruction requiring fixation of bone-Patellar Tendon-bone grafts.

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

• Linvatec Corporation Concept Cannulated Interference Screw
• Mitek Ligament Anchor

Submission Summary (Full Text)

{0}

K954683
APR 23 1996

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

Contact Person: Cliff Kline
Date: October 6, 1995

510(k) SUMMARY

Trade/Proprietary Name: QuestLock ACL Fixator
Common Name: Staple, fixation, bone device
Classification: Class II
Predicate Devices: The Linvatec Corporation Concept Cannulated Interference Screw and the Mitek Ligament Anchor

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 QuestLock ACL Fixator is intended to provide a means for firmly securing a bone-Patellar Tendon-bone graft during reconstruction of an Anterior Cruciate Ligament (ACL). The fixator is made from Titanium alloy.

Substantial Equivalence

The QuestLock ACL Fixator is substantially equivalent to the The Linvatec Corporation Concept Cannulated Interference Screw and the Mitek Ligament Anchor.

Testing

The QuestLock ACL Fixator demonstrates acceptable pull out strengths.

000047