NovaLign Intramedullary Fixation System (IFS) for the Treatment of Humeral Fractures

This is an observational, prospective, nonrandomized open label, post-market clinical study,
designed to evaluate the use a flexible intramedullary fixation device used in the treatment
of fractures of the humerus. This is a multicentre trial.

Inclusion Criteria:

- Humeral Fracture

- Surgical intervention can be performed within 14 days of injury (injury being Day 0
for this particular criteria)

- Fully functioning contralateral limb (e.g., hand, arm, shoulder)

- Age 18 years or older and skeletally mature

Exclusion Criteria:

- Intraarticular fractures or those involving shoulder or elbow of the index arm

- Pathologic fracture (e.g., tumor involvement, osteomalacia, etc.; osteoporosis is not
an exclusion)

- Evidence of neurologic injury in the index arm, including compartment syndrome or
radial nerve palsy

- Additional upper body injuries (e.g., upper extremity, abdominal, thoracic, neck or
head injury) that may affect or inhibit the evaluation of the index or contralateral
arm, shoulder, elbow, etc or would not allow the patient to follow or comply with
appropriate post-operative regimens

- Any previous bodily injury or surgery that may interfere with function or evaluation
of index or contralateral arm, shoulder, elbow, etc.