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DirectGen®

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MINERALIZED ALLOGRAFT

Cancellous Particulate

DirectGen Mineralized cancellous particulate has the interconnecting porosity associated with trabecular bone structure. This allows for increased capillary action of the blood which in turn promotes rapid formation of osteoblasts for new bone growth.

Mineralized Allograft

Why DirectGen™DirectGen™ Mineralized Allograft is a natural, safe and easy to use grafting material. This product comes in a variety of donated tissue types (cortical, cancellous or cortical-cancellous blend) and is suited for a wide range of clinical needs.

• Has increased porosity and surface area for new bone formation• Resorbs completely

Cortical Particulate

DirectGen Mineralized cortical particulate offers the structural strength and integrity associated with cortical bone. This results in a slower resorbing graft material that is ideal for space maintenance in grafting procedures.

• Provides longer lasting scaffold for new bone ingrowth• Resorbs completely

Cortical/ Cancellous Blend

DirectGen Mineralized Blend is a 50:50 mixture of cortical and cancellous particulate. This pre-mixed easy to use product is intended to provide the clinician with the features and benefits of both tissue types.

• Simplifies procedure by eliminating need to mix tissues chair side• Single donor per vial • Resorbs completely

Bone Grafting

Safe and Easy to UseDirectGen has been processed utilizing the proprietary AlloTrue™ process. This process allows for microbial inactivation while minimally manipulating the tissue. This process meets or exceeds requirements set forth by the FDA and American Association of Tissue Banks (AATB) and as a result AlloSource has not had a confirmed case of disease transmission from allografts in its 17-year history.

2 Initial Process of Tissue• Tissue undergoes physical inspection prior to any processing. Tissue then undergoes

debridement process in ISO class 5-7 clean rooms• Each lot of processed tissue is from a single donor

1 Donation Process• Tissue is donated through a certified Organ Procurement Organization (OPO)• Strict screening of donors and donated tissue includes in depth review of donors’ medical

history and extensive serological and microbiological testing of the donated tissue

3 Preparation for Cleaning Process• Tissue is carefully weighed and then subjected to a proprietary combination of

cleansing and reagents

4 AlloTrue Cleaning Process• Tissue is subjected to a deep penetrating cleaning process that relies on a proprietary

combination of additional cleansing reagents with computer-controlled mechanical processes

5 Post Treatment• Tissue undergoes additional microbial inspections and then is terminally sterilized

(10 -6 SAL) through use of low dosage gamma radiation

6 Clinical Use• Product does not require any special storage conditions and can be quickly

hydrated prior to use

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Allograft: DirectGen Mineralized Cortical Item#

(250-1000μm) - 0.5cc DMCO251005

(250-1000μm) - 1.0cc DMCO251010

(250-1000μm) - 2.0cc DMCO251020

(1000-2000μm) - 0.5cc DMCO102005

(1000-2000μm) - 1.0cc DMCO102010

(1000-2000μm) - 2.0cc DMCO102020

Allograft: DirectGen Mineralized Cancellous Item#

(250-1000μm) - 0.5cc DMCA251005

(250-1000μm) - 1.0cc DMCA251010

(250-1000μm) - 2.0cc DMCA251020

(1000-2000μm) - 0.5cc DMCA102005

(1000-2000μm) - 1.0cc DMCA102010

(1000-2000μm) - 2.0cc DMCA102020

Allograft: DirectGen Mineralized Cortical/ Item#Cancellous blend

(250-1000μm) - 0.5cc DMB251005

(250-1000μm) - 1.0cc DMB251010

USA 1-888-649-6425

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DirectGen™

(250-1000μm) - 2.0cc DMB251020