Study Performance of The Plexur P™ Bone Void Filler Device in Patients Undergoing Iliac Crest Harvesting Procedures

This prospective trial is designed to evaluate the ability of the Plexur P device (bone void
filler) to reconstitute the iliac crest in patients requiring iliac crest bone harvesting
procedures at one single study site.

Plexur P Bone Void Filler is:

- A biocomposite of mineralized cortical allograft bone fibers and
polylactide-co-glycolide co-polymer.

- Designed to fill bony voids or gaps of the skeletal system that are not intrinsic to the
stability of the bony structure.

- Porosity is introduced into the Plexur P Biocomposites to create a cancellous-like
structure that provides a scaffold for bone growth.

In addition:

- Patients will be screened for study eligibility based on the need for iliac crest bone
harvesting.

- Fifteen (15) eligible patients will be enrolled and will have an iliac crest harvesting
defect backfilled with Plexur P to repair the iliac crest defect.

- As a part of routine follow up care, patient related outcomes including measurements of
pain severity and pain relief will be determined using patient (IRB approved)
questionnaires.

- Radiographic analysis will also be used to determine amount of bony ingrowth of the
Plexur P device.

Inclusion Criteria:

- The patient is at least 18 yrs old.

- The patient requires an iliac crest harvesting procedure.

- The patient has signed an Informed Consent, approved by the IRB.

Exclusion Criteria:

- Patient is less than 18 years old.

- Patient presents with a bony void or gap in an area other than the iliac crest and/or
has an infection present at the (operative) site.

- Insulin dependent diabetics and/or in the opinion of the investigator, has poorly
controlled non-insulin dependent diabetes.

- The patient is a smoker.

- The patient is mentally compromised (e.g., currently being treated from a psychiatric
disorder, senile dementia, Alzheimer's disease, etc.) and/or in the opinion of the
investigator, is not likely to complete follow up visits;

- The patient has a bleeding disorder of any etiology, severe vascular or neurological
disease;

- The patient has hypercalcemia and/or severe degenerative bone disease;

- The patient has a history of long term steroid use;

- The patient requires immunosuppressive therapy;

- The patient has a history of drug or alcohol abuse that may interfere with his/her
ability to provide written informed consent;

- The patient is pregnant at the time of study entry or may likely become pregnant
during the course of study participation;

- The subject has an implanted device, which is incompatible with the use of imaging
equipment;

- The patient has an allergy to one of the components of the investigational device;

- The patient has renal insufficiency;

- The patient has a terminal illness.