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510(k) Data Aggregation
K Number
K103036Device Name
ALLOFUSE PLUS
Manufacturer
ALLOSOURCE, INC.
Date Cleared
2011-01-10
(89 days)
Product Code
MQV, MBP
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
ALLOSOURCE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For orthopedic use, AlloFuse Plus Paste and Putty are intended for use as an autograft extender (i.e. extremities, posterolateral spine and pelvis) and as a bone void filler (i.e. extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure. The AlloFuse Plus products are indicated to be packed gently into bony defects of the skeletal system. These defects may be surgically created or from the result of traumatic injury to the bone.
Device Description
AlloFuse Plus is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor and formulated into a paste or putty-like consistency.
The carrier is a solution of polvethylene oxide polypropylene oxide block copolymer dissolved in water exhibiting reverse phase characteristics (i.e. an increase in viscosity as temperature increases).
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K Number
K071849Device Name
ALLOFUSE GEL AND PUTTY
Manufacturer
ALLOSOURCE, INC.
Date Cleared
2008-12-04
(518 days)
Product Code
MQV, MBP
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
ALLOSOURCE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse® is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender (extremities, spine, and pelvis) and as bony void filler of the extremities and pelvis. These defects may be surgically created or from the result of traumatic injury to the bone.
Device Description
AlloFuse is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated into a gel or putty-like consistency.
The carrier is a solution of polyethylene oxide polypropylene oxide block copolymer dissolved in water exhibiting reverse phase characteristics (i.e. an increase in viscosity as temperature increases).
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