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The DIGIFIX™ External Fixation System is intended to be used in skeletally mature patients in treatment of: DYNAMIC MODE: 1) complex fracture-dislocations or fracture-subluxation, unstable dislocations, and pilon fractures of the interphalangeal (IP) joint; 2) Post-traumatic joint contracture of the proximal interphalangeal (PIP) joint; STATIC MODE: 1) comminuted fractures of the phalanges and 2) interphalangeal (IP) joint arthrodesis.

The DigiFix™ External Fixation System includes various elements including brackets, locking pins, set screws and k-wires. The elements are used to create an assembled frame which capture and support the k-wires on the medial and lateral aspect of finger. The brackets, locking pins and set screws are assembled intraoperatively. External fixator components are provided non-sterile and are intended for single use only.

The provided text does not contain information about acceptance criteria or a study proving that the DigiFix™ External Fixation System meets such criteria. Instead, it states that
"A device which has essentially the same design and materials as the predicate should not require testing unless there is new information which raises safety and effectiveness concerns. The DigiFix™ device utilizes materials and has design features that are the predicate devices. Evaluation of the material, dimensions and K-wires demonstrates that the subject device has a higher estimated rigidity than the predicate devices. Thus, no performance testing is necessary to support substantial equivalence of the device."

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study that proves the device meets those criteria.

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