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Directions for Use

Directions for Use
Familiarization with the device and following proper surgical grafting techniques are extremely important when using GEM 21S® Growth-factor Enhanced Matrix. Radiographic evaluation of the defect site prior to use is essential to accurately assess the extent of the defect and to aid in the placement of the grafting material.

Following exposure of the defect, with a full thickness mucoperiosteal flap, all granulation tissue must be carefully removed. Thorough soft tissue debridement of the defect is critical to successful regeneration. Granulation tissue, if left in the defect, could be stimulated by the rhPDGF-BB component, diminishing the desired regenerative response. Exposed tooth root surfaces should also be thoroughly planed.

Following thorough debridement of the osseous defect, the clinician, based on his or her experience, estimates the amount of GEM 21S® needed to fill the defect. For best results, GEM 21S® must completely fill the defect to the level of the surrounding bony walls. Overfilling should be avoided. The clinician prepares the GEM 21S® graft by fully saturating the β-TCP particles with the rhPDGF-BB solution and letting the product sit for approximately ten (10) minutes.

The saturated GEM 21S® should be placed into the defect using moderate pressure, taking care not to crush the particles. In order to enhance the formation of new bone, GEM 21S® should be placed in direct contact with well-vascularized bone. Excessive bleeding should be controlled prior to placing grafting materials. Following placement of the GEM 21S® and completion of any additional surgical steps, the mucoperiosteal flaps should be sutured to achieve primary closure wherever possible.

GEM 21S® is supplied as a single use kit. Any remaining product must be discarded and not reused.

Postoperative patient management should follow the same regimen as similar cases utilizing autogenous bone grafting. Prerequisites for all regenerative procedures include prevention of wound dehiscence, a stable clot, and minimal bacterial contamination.
 
Clinical Instructions
GEM 21S® Growth-factor Enhanced Matrix contains a recombinant human platelet derived growth factor (rhPDGF-BB) and a synthetic beta-tricalcium phosphate matrix (β-TCP).

Sterility
All components/accessories are supplied sterile for single use only. The external surface of the rhPDGF-BB syringe and β-TCP cup are not sterile. Therefore, care must be taken to ensure that these components are handled in such a way that sterility is maintained in the surgical field. The GEM 21S® kit and its components must not be resterilized.

Aseptic Technique and Preparing GEM 21S®
This information is supplementary to the GEM 21S® directions for use (see below). Familiarization with the device, proper sterile surgical grafting techniques, and thorough debridement of the bony defect are extremely important.

  
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