(175 days)
NovaBone Bioactive Strip bone graft devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Bioactive Strip is indicated to be gently placed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NovaBone Bioactive Strip must be hydrated with autogenous bone marrow aspirate prior to implantation. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
NovaBone BIOACTIVE Strip is an osteoconductive bioactive device used for grafting osseous defects. The device is a mixture of bioactive calcium-phosphosilicate granules and a collagen binder. The bioactive glass particulate is composed solely of elements that exist in normal bone (Ca, P, Na, Si, O). The binder consists of bovine collagen. When hydrated with bone marrow aspirate, the device absorbs fluids to form a flexible graft matrix that is applied directly to the intended graft site. During healing, the graft particulate is absorbed and remodeled into new bone.
BIOACTIVE Strips are flexible after hydration and are not intended to be loadbearing. Therefore, bulk physical /mechanical properties such as compressive and tensile strengths are not applicable to device properties. The device is sterilized to a sterility assurance level of 100 using ethylene oxide.
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§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.