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510(k) Data Aggregation
K Number
K140844Device Name
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC
Manufacturer
Date Cleared
2014-07-16
(105 days)
Product Code
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
SYNERGY BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BioSphere Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSphere Putty is indicated to be gently packed into bony voids or gaps of the skeletal system as a bone void filler in the extremities and pelvis, and as a bone graft extender in the posterolateral spine. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Device Description
BioSphere Putty Bioactive Bone Graft (BioSphere Putty) is an osteoconductive, bioactive bone void filler that, like its predicate device, is composed of 45S5 bioactive glass particles. In BioSphere Putty, the bioactive glass is mixed with an inert, moldable carrier that aids in placement of the product into bony voids. Upon implantation, the carrier is absorbed by the site and the remaining bioactive glass particles provide an osteoconductive surface for bone formation. The bioactive glass particles are provided in a spherical form, and the natural packing of the spheres creates 3-dimensional, interconnected porosity that allows for bone regeneration throughout the defect site. In the posterolateral spine, BioSphere Putty can be combined with autograft as a bone graft extender.
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