Collagen Bone Graft: Collagen Granules and Sheet - SunMax Porcine Collagen Products


Bone Void Filler - Strip		Bone Void Filler - Granules

※ The product holds a CE Mark .

■ Product Information■

-- Description
Sunmax Collagen Bone Graft Matrix is a mixture consisting of bioresorbable purified fibrillar collagen and hydroxyapatite / ß-tricalcium phosphate (HAp / ß-TCP) ceramic.
The highly purified collagen component is porcine dermal type I collagen. The ceramic portion of Sunmax Collagen Bone Graft Matrix is radiopaque and with HAp / ß-TCP
ratio: 65 / 35 ~ 60 / 40.
The HAp is a polycrystalline substance with a stoichiometry similar to bone mineral.
The ß-TCP has a stoichiometry similar to amorphous biologic precursors to bone. In addition, it is biodegradable and its biodegradation products can be reconstituted by the body to form new bone mineral, allowing for bone deposition to occur.

Sunmax Collagen Bone Graft Matrix is provided as a sterile, non-pyrogenic, single use, ready to use, implantable device that is intended for use as a bone void filler that is resorbed, remodeled and replaced by the growth of new bone during the course of the natural healing process for defects of the skeletal system. Sunmax Collagen Bone Graft Matrix is a biocompatible, osteoconductive, porous implant that allows for bony ingrowth into the graft space while resorbing at a rate consistent with bone healing.
Sunmax Collagen Bone Graft Matrix may be mixed with autogenous blood products such as bone marrow prior to use to possess an osteoinductive property for filling bone defects.
The device is sterilized by γ-irradiation and is supplied in granule, block or strip forms.

-- Indications for use
Sunmax Collagen Bone Graft Matrix, when coated with autogenous bone marrow, is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure.

Sunmax Collagen Bone Graft Matrix should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis).

These defects may be surgically created osseous defects or defects created from traumatic injury to bone. No defect should be greater than 30 ml.

Sunmax Collagen Bone Graft Matrix provides a bone void filler that is resorbed and replaced with bone during the healing process.

-- Direction for use

1. Preoperative procedure
In the incidence of an open fracture, initial debridement and wound management should be performed. Exercise care to minimize periosteal stripping. Contaminated wounds must be treated and eradicated prior to the graft procedure. Use prophylactic antibiotic coverage as appropriate.
All procedures should be performed in the operative room under aseptic conditions.

2. Surgical procedure
Follow accepted procedures for grafting with fixation. Bone marrow may be obtained from the iliac crest, using standard bone marrow collection techniques. If marrow from the fracture site is used, it is important that the marrow has not been contaminated.

Transfer Sunmax Collagen Bone Graft Matrix to a sterile tray, followed by the addition of sterile saline. Then allow Sunmax Collagen Bone Graft Matrix to hydrate for 1 to 3 minutes. After hydration, transfer Sunmax Collagen Bone Graft Matrix to another sterile tray containing bone marrow and coat all surfaces with marrow. Add 1ml of bone marrow per ml of Sunmax Collagen Bone Graft Matrix. The Sunmax Collagen Bone Graft Matrix may be used directly or be molded to fit the defect shape.

It is important to mold gently to avoid crushing the strips/blocks/granules or damaging the marrow cells. The defect site should be filled as completely as possible. In weight bearing situations, Sunmax Collagen Bone Graft Matrix is to be used in conjunction with internal fixation devices.

-- How supply
Sunmax Collagen Bone Graft Matrix, a sterile ( γ -irradiation) bone graft substitute, is supplied in prefabricated strips/blocks/granules of various volumes.

Granule
– 1 cc/vial ＊ 5 cc/vial ＊ 10 cc/vial
– 20 cc/vial ＊ 30 cc/vial
Block
– 10 mm x 10 mm x 10 mm (l x w x h), 1 block/vial
– 10 mm x 10 mm x 10 mm, 2 block/vial
Strip
– 45 mm x 15 mm x 3 mm (l x w x h), 1 strip/vial
– 45 mm x 15 mm x 3 mm, 2 strip/vial
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Products: Collagen Bone Graft Matrix