The AlloMax™ 1mm Surgical Graft is a human ADM (acellular dermal matrix) specifically designed with a tight tolerance of 1mm+/- 0.2mm to ensure consistency between grafts providing greater precision. It is prepared using the Tutoplast® process - with a 40-year history of safety and proven results - to remove all non-collagenous cellular components.

Benefits

Symmetry: Consistent graft thickness to help support a uniform repair.

Sterility: AlloMax™ meets or exceeds a sterility assurance level (SAL) of 10-6 which is what the FDA recommends for medical devices intending to come in contact with breached skin or compromised tissue.

Science: Preclinical data demonstrating proven blood vessel formation in as little as 7 days.1*

* Preclinical results may not correlate to performance in humans.
The AlloMax™ Surgical Graft is processed by RTI Biologics.


Reference:
1Greenspan, David C., Ph.D et al. Histology of Surgically Implanted AlloMax™ Surgical Graft.

Ordering Information

    • 1180508M
    • 1/cs.
    • 2.0" x 3.1" (5 cm x 8 cm) Rectangular
    • 1180412M
    • 1/cs.
    • 1.6" x 4.7" (4 cm x 12 cm) Rectangular
    • 1180416M
    • 1/cs.
    • 1.6" x 6.3" (4 cm x 16 cm) Rectangular
    • 1180710M
    • 1/cs.
    • 2.8" x 3.9" (7 cm x 10 cm) Rectangular
    • 1180612M
    • 1/cs.
    • 2.4" x 4.7" (6 cm x 12 cm) Rectangular
    • 1180616M
    • 1/cs.
    • 2.4" x 6.3" (6 cm x 16 cm) Rectangular
    • 1180812M
    • 1/cs.
    • 3.1" x 4.7" (8 cm x 12 cm) Rectangular
    • 1180816M
    • 1/cs.
    • 3.1" x 6.3" (8 cm x 16 cm) Rectangular
    • 1181015M
    • 1/cs.
    • 3.9" x 5.9" (10 cm x 15 cm) Rectangular
    • 1180820M
    • 1/cs.
    • 3.1" x 7.9" (8 cm x 20 cm) Rectangular
    • 1181620M
    • 1/cs.
    • 6.3" x 7.9" (16 cm x 20 cm) Rectangular

Accessories

AlloMax™ and AlloMax™ 1mm Surgical Grafts are restricted to homologous use for the repair, replacement, reconstruction or augmentation of soft tissue by a qualified healthcare professional (i.e., physician). This includes supplemental support and reinforcement of soft tissue in hernia repair, chest wall defect procedures and grafting for horizontal and vertical soft tissue augmentation of thickness and length such as post-mastectomy breast reconstruction. The implant is provided sterile and requires rehydration prior to use.

Warnings
The same potential medical/surgical conditions or complications that apply to any surgical procedure may occur during or following implantation. The surgeon is responsible for informing the patient of the risks associated with their treatment and the possibility of complications or adverse reactions. As with any human tissue implant, it is not possible to guarantee freedom from transmission of infectious agents or other adverse reactions such as hypersensitivity, allergic or immune response.

Precautions
Prior to use, the surgeon must become familiar with the implant and the surgical procedure. Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for procedures using this implant; as such conditions may compromise outcomes. The implant should be used with caution in surgical sites where an active infection is present or in sites with poor perfusion. If the surgeon determines that the clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken. Appropriate placement and fixation of the implant are critical to success of the surgical procedure.

DAV/AMBR/1016/0046