Oxford Mark 2 External Fixator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K833114 ↗

FDA Product Code

JEC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What is the Oxford Mark 2 External Fixator used for?

  The Oxford Mark 2 External Fixator is designed to stabilize and support bone fractures or deformities externally. It applies controlled traction and alignment through pins, rods, and connecting rings to facilitate skeletal realignment and promote proper bone healing in complex orthopedic cases, such as trauma or surgical interventions requiring external stabilization.

• Is the Oxford Mark 2 External Fixator reusable or single-use?

  The Oxford Mark 2 External Fixator is supplied as a reusable medical device. It is intended for use in clinical settings like hospitals and orthopedic surgery centers, where it can be assembled and disassembled as needed for patient-specific anatomical requirements.

• What components does the Oxford Mark 2 External Fixator include?

  The Oxford Mark 2 External Fixator system includes multiple components such as pins, rings, and connecting rods. These parts are assembled to match the specific anatomical needs of the patient, ensuring proper stabilization and alignment of the bone.

• How should the Oxford Mark 2 External Fixator be handled in terms of sterility?

  While the regulatory data does not specify sterility requirements for the device itself, standard surgical aseptic techniques must be followed during use. This ensures that the fixator and its components are handled in a sterile manner to prevent infection and maintain patient safety.

• What regulatory clearance does the Oxford Mark 2 External Fixator hold?

  The Oxford Mark 2 External Fixator holds FDA 510(k) clearance under the classification of Device Class 2, with the clearance number K833114. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed device and meets regulatory standards for safety and effectiveness.