Post Market Clinical Evaluation of Gamma 4

Inclusion Criteria:

• Subject is a male or non-pregnant female age 18 years or older at the time ofsurgery;

• Subject is willing and able to give written informed consent and comply with therequirements of this Clinical Investigation Plan; and

• Subject has or is intended to be treated with the Gamma 4 System in accordance withits legally approved Indication for Use (IFU).

Indication For Use in the United States and Canada:

The Gamma4 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).

Exclusion Criteria:

• Subject is currently enrolled in or plans to enroll in any concurrent drug and/ordevice clinical investigation that, in the opinion of the Investigator, may confoundresults

• Subject with exclusion criteria required by local law

• Subject who is, or will be, inaccessible for follow-up

• Per the Investigator, the subject is in poor general health or undergoing anyconcurrent disease that would place the subject in excessive risk to surgery (i.e.,significant circulatory problems, cardiac disease).

• Any active or suspected latent infection or marked local inflammation in or aboutthe affected area

• Compromised vascularity that would inhibit adequate blood supply to the fracture orthe operative site

• Bone stock compromised by disease, infection or prior implantation that cannotprovide adequate support and/or fixation of the devices

• Material sensitivity, documented or suspected

• Patients having inadequate tissue coverage over the operative site

• Implant utilization that would interfere with anatomical structures or physiologicalperformance

• Any mental or neuromuscular disorder which would create an unacceptable risk offixation failure or complications in postoperative care

• Other medical or surgical conditions which would preclude the potential benefit ofsurgery.