Ellis External Mini-Fixator System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K964458 ↗

FDA Product Code

KTT

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What is the Ellis External Mini-Fixator System used for?

  The Ellis External Mini-Fixator System is used for the stabilization of fractures and joint fusion procedures, specifically indicated for fixation of fractures of the proximal or distal end of long bones, including intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur, as well as for fusion of a joint or surgical procedures involving bone cutting.

• How is the Ellis External Mini-Fixator System supplied and is it reusable?

  The device is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization by the user, meaning it must be cleaned and sterilized by the healthcare facility before each use to ensure safety and effectiveness.

• What regulatory pathway was used for the Ellis External Mini-Fixator System?

  The Ellis External Mini-Fixator System is regulated as a Class II medical device under FDA 510(k) clearance (K964458) with product code KTT, and was determined to be substantially equivalent to a predicate device, meaning it met the requirements for substantial equivalence through the traditional 510(k) pathway.