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QuestLock ACL Fixator

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K954683

Overview

The QuestLock ACL Fixator is a Fastener, Fixation, Nondegradable, Soft Tissue device, classified under product code MBI. It is designed as a secure anchoring system for soft tissue fixation, specifically intended for use in orthopedic procedures.

This device is supplied sterile and intended for single-use, providing a means to firmly secure a bone-Patellar Tendon-bone graft during Anterior Cruciate Ligament (ACL) reconstruction. It holds FDA 510(k) clearance (K954683) under the Traditional pathway, with no third-party review. Storage and handling must comply with sterile medical device protocols.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK954683 Date23 Apr 1996ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MBI
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the QuestLock ACL Fixator intended for?

    The QuestLock ACL Fixator is designed as a secure anchoring system for soft tissue fixation, specifically intended for use in orthopedic procedures to firmly secure a bone-Patellar Tendon-bone graft during Anterior Cruciate Ligament (ACL) reconstruction.

  • How is the QuestLock ACL Fixator supplied and is it reusable?

    The device is supplied sterile and intended for single-use only, meaning it should not be reprocessed or reused after initial application to maintain sterility and performance integrity.

  • What regulatory pathway was used for the QuestLock ACL Fixator's market authorization?

    The QuestLock ACL Fixator received FDA 510(k) clearance (K954683) through the Traditional pathway, with no third-party review involved in the submission process.

  • What product code classifies the QuestLock ACL Fixator and what does it signify?

    The device is classified under product code MBI, which categorizes it as a Fastener, Fixation, Nondegradable, Soft Tissue device within the FDA's product code system for orthopedic fixation devices.

  • What storage and handling requirements apply to the QuestLock ACL Fixator?

    Storage and handling must comply with sterile medical device protocols to preserve the device's sterility and functionality until point of use, as it is provided in a sterile, single-use condition.