Integros Bone Plus‐XS
USAGE INSTRUCTIONS

Intended for use as bone void filler for bony voids or gaps of the skeletal system, caused by surgical incision, osseous defects or traumatic injury results to the bone.

Can be mixed with autograft, bone marrow, platelet-rich plasma (PRP) or other bone graft substitutes to increase the volume of auto grafts and accelerate their effects.

Indicated for:

• Filling of traumatic or pathologic bone cavities
• Fractures with bone defects
• Pseudo arthrosis with or without bone defects
• Tibial osteotomy
• In all bony repairs according to surgeon decision

Integros Bone Plus-XS has limited initial mechanical properties; therefore, this product is contra indicated where the device is intended as structural support in the skeletal system.

Contraindications also include:

• Acute or chronic osteomyelitis
• Impaired blood supply or necrosis at the recipient site
• Degenerative bone disease in the limb to be treated
• Intra‐articular implantations
• Uncontrolled metabolic diseases (diabetes, hyperparatyroid, osteomalasia)
• Severely impaired renal or hepatic function

In the case of certain treatments under way, with corticoids or with drugs acting on the phosphocalcic metabolism, the use of Integros Bone Plus‐XS must be very carefully evaluated.

After exposure of the bony defect, all inflammatory tissue and debris must be carefully removed.

The surgical site should be cleansed with sterile saline and aspirated to prepare the bone for the placement of Integros Bone Plus‐XS.

Hydrate Integros Bone Plus‐XS with sterile saline or patient’s blood in a sterilized dish.

In order to expect well formation of new bone, Integros Bone Plus‐XS should only be placed in direct contact with well vascularized bone.

Transfer Integros Bone Plus‐XS to defect site using a sterile instrument.

Fill in the defect site with Integros Bone Plus‐XS graft loosely to avoid crushing of particles and loss of trabecular architecture.

Cover flaps and suture tightly in place not to be exposure.

Site grafted with Integros Bone Plus‐XS should be allowed to heal approximately 6 months prior to implant placement.

The effect of usage under the conditions indicated below are unknown:

• Pregnancy and nursing
• Pediatric patients
• Patients with a preexisting disease condition

• Single use only
• Don’t reuse
• Don’t resterilize
• Not intended for immediate load bearing
• Don’t overfill or leave defects open
• Blood supply to the defect area should not be compromised
• Don’t apply excessive force when implanting Integros Bone Plus‐XS at the surgical site
• Recommended that cover at the implant site using membrane when filling Integros Bone Plus-XS
• Use these products at the enough blood supply and hone contact site
• Don’t use if package is opened or damaged or it expiration date has been exceeded
• The implantation of titanium fixtures should not take place until about 6 months after the use of Integros Bone Plus‐XS 
• Should be protected against contamination
• Use under sterilize conditions
• Open product just before operation

• No adverse reactions have been reported until today
• It could appear local complication of edema, sutures margin, bleeding after surgery, ulcer of soft tissue, infection etc.
• Resorption rate may change from patient to another one
• Bone deformity and loss of contour at the implantation site can be observed

 ‐ Store in room temperature and dry place
 ‐ Optimal storage conditions 5°C ‐ 40°C and max
 – Store between 10% to %60 relative humidity
 ‐ Storage under direct sunlight should be avoided
 ‐ The expiration and manufacturing date is printed on the label
 ‐ Shelf life is 5 years