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510(k) Data Aggregation
K Number
K142104Device Name
NANOFUSE DBM
Manufacturer
NANOTHERAPEUTICS, INC.
Date Cleared
2015-01-21
(173 days)
Product Code
MQV, MBP
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
NANOTHERAPEUTICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NanoFUSE® DBM is indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e., the extremities, pelvis and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NanoFUSE® DBM must be used with autograft as a bone graft extender in the posterolateral spine. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
Device Description
NanoFUSE® DBM is a malleable, putty-like, bone-void filler for use in general orthopedic applications. The product is comprised of human demineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles (45s5 bioactive glass), both coated with gelatin derived from porcine skin. These coated particles are packaged dry in a single use, polypropylene syringe (20 cc or 3 cc), double-wrapped in peel-back pouches, and final packaged in a dust cover paperboard carton. The 20 cc syringe will be filled with either of two different fill quantities of dry powder, identified as 10 cc or 5 cc final product volume. The 3 cc syringe will be filled with dry powder, identified as 2 cc final product volume. NanoFUSE® DBM is intended for single patient use only. At point of use, the surgeon will reconstitute the product with an appropriate sterile solution of his/her choice (sterile saline, water for injection, or autologous whole blood). The coated particles rehydrate in less than 30 seconds and do not require mixing to form a uniform paste or putty. The material is then gently extruded by the surgeon into the appropriate bone voids. NanoFUSE® DBM is progressively resorbed and replaced by host bone during the osteo-remodeling process.
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K Number
K120279Device Name
NANOFUSE DBM
Manufacturer
NANOTHERAPEUTICS
Date Cleared
2012-04-06
(67 days)
Product Code
MQV, MBP
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
NANOTHERAPEUTICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NanoFUSE® DBM is indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. It is indicated to be placed into bony voids or gaps of the skeletal structure (e.g., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
Device Description
NanoFUSE® DBM is a malleable, putty-like, bone-void filler. The product is comprised of human demineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles (45s5 bioactive glass), both coated with gelatin derived from porcine skin. These coated particles are packaged dry in a single use, polypropylene syringe (20 cc or 3 cc), double-wrapped in peel-back pouches, and final packaged in a dust cover paperboard carton. The 20 cc syringe will be filled with either of two different fill quantities of dry powder, identified as 10 cc or 5 cc final product volume. The 3 cc syringe will be filled with dry powder, identified as 2 cc final product volume. NanoFUSE® DBM is intended for single patient use only. At point of use, the surgeon will reconstitute the product with an appropriate sterile solution of his/her choice (sterile saline, water for injection). The coated particles rehydrate in less than 30 seconds and do not require mixing to form a uniform paste or putty. The material is then gently extruded by the surgeon into the appropriate bone voids. NanoFUSE® DBM is progressively resorbed and replaced by host bone during the osteo-remodeling process.
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K Number
K110976Device Name
ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM
Manufacturer
NANOTHERAPEUTICS, INC.
Date Cleared
2011-05-03
(26 days)
Product Code
MQV, MBP, MOV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
NANOTHERAPEUTICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Origen DBM® with Bioactive Glass (NanoFUSE® DBM) is indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. It is indicated to be placed into bony voids or gaps of the skeletal structure (e.g., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
Device Description
Origen DBM® with Bioactive Glass (also registered with the FDA as NanoFUSE® DBM) is a malleable, putty-like, bone-void filler for use in general orthopedic applications. The product is comprised of human demineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles (45s5 bioactive glass), both coated with gelatin derived from porcine skin. These coated particles are packaged dry in a single use, polypropylene syringe (20 cc or 3 cc), double-wrapped in peel-back pouches, and final packaged in a dust cover paperboard carton. The 20 cc syringe will be filled with either of two different fill quantities of dry powder. identified as 10 cc or 5 cc final product volume. The 3 cc syringe will be filled with dry powder, identified as 2 cc final product volume. Origen DBM® with Bioactive Glass (NanoFUSE® DBM) is intended for single patient use only. At point of use, the surgeon will reconstitute the product with an appropriate sterile solution of his/her choice (sterile saline, water for injection). The coated particles rehydrate in less than 30 seconds and do not require mixing to form a uniform paste or putty. The material is then gently extruded by the surgeon into the appropriate bone voids. Origen DBM® with Bioactive Glass (NanoFUSE® DBM) is progressively resorbed and replaced by host bone during the osteo-remodeling process.
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K Number
K062459Device Name
ORIGEN DBM WITH BIOACTIVE GLASS
Manufacturer
NANOTHERAPEUTICS
Date Cleared
2007-02-26
(187 days)
Product Code
MQV, MBP
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
NANOTHERAPEUTICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Origen™ DBM with Bioactive Glass is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be placed into bony voids or gaps of the skeletal system (e.g., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
Device Description
Origen™ DBM with Bioactive Glass is a malleable, putty-like bonevoid filler. The product is comprised of human demineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles, both coated with gelatin derived from porcine skin. These coated particles are packaged dry in a single use, polypropylene syringe (20 cc or 5 cc), double-wrapped in peel-back pouches, and final packaged in a dust cover paperboard carton. The 20 cc syringe will be filled with either of two different fill quantities of dry powder, identified as 10 cc or 5 cc final product volume. The 5 cc syringe will be filled with two additional fill quantities of dry powder, identified as 2.5 cc or 1 cc final product volume. Origen™ DBM with Bioactive Glass is intended for single patient use only. At point of use, the surgeon will reconstitute the product with an appropriate sterile solution of his/her choice (WFI, sterile normal saline). The coated particles rehydrate in less than 30 seconds and do not require mixing to form a uniform paste or putty. The material is then gently extruded by the surgeon into the appropriate bone voids. Origen™ DBM with Bioactive Glass is progressively resorbed and replaced by host bone during the osteo-remodeling process.
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