True/Lok Monolateral/Bilateral Fixator

• • Terminated Z-0674-2008 FDA Unclassified (pre-2012) ·initiated 28 Sep 2007

  Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted.

510(k) Number

K941048 ↗

FDA Product Code

LXT

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Applied Osteo Systems, Inc. →

• What is the primary clinical purpose of the True/Lok Fixator?

  This device is designed for orthopaedic bone and joint treatment. It is used to provide structural support for fracture stabilization, deformity correction, or distraction when utilized alongside an invasive bone pin.

• How is the True/Lok Fixator classified for regulatory purposes?

  The device is regulated as a metal composite fixation appliance. It has received FDA 510(k) clearance under reference number K941048, which confirms its status as substantially equivalent to existing devices.

• Does the True/Lok Fixator require an external power source?

  No, the True/Lok Monolateral/Bilateral Fixator is a non-powered, noninvasive structural component. It functions as a mechanical appliance within an external orthopaedic fixation system.