Search Results
Found 4 results
510(k) Data Aggregation
K Number
K160446Device Name
MCP Bone Putty
Manufacturer
BioStructures, LLC
Date Cleared
2016-11-07
(264 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
BioStructures, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MCP Bone Putty is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. MCP Bone Putty is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, MCP Bone Putty is to be used as an autograft extender. The device resorbs and is replaced by host bone during the healing process.
Device Description
MCP Bone Putty is a bone graft substitute comprising biphasic mineral granules suspended in a porous type I collagen matrix, provided terminally sterile and for single patient use. The device is to be combined with autologous bone marrow aspirate to facilitate packing into bony defects and upon implantation, provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
Ask a Question
K Number
K142276Device Name
MCS Bone Graft
Manufacturer
BIOSTRUCTURES, LLC
Date Cleared
2015-01-16
(154 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
BIOSTRUCTURES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MCS Bone Graft is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MCS Bone Graft is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities and pelvis) and is used mixed with bone marrow aspirate. Once implanted, the device resorbs and is replaced with host bone during the healing process.
Device Description
Device Identification and Materials of Use:
MCS Bone Graft is a resorbable bone void filler device comprised of biphasic mineral granulate suspended in a porous type I collagen matrix.
Device Characteristics:
The implant is designed to be hydrated with bone marrow aspirate prior to implantation to facilitate handling and placement in bony defects. The device is supplied freeze dried in strip form, and packaged in a sterile barrier foil pouch. The device is provided sterile, for single use, in a variety of sizes.
Body Contact:
The device is a permanent resorbable implant in bone tissue
Mechanism of Action:
The device's composition allows for resorption and remodeling over time. It is an osteoconductive scaffold for new bone regeneration.
Ask a Question
K Number
K132071Device Name
BIOACTIVE BONE GRAFT PUTTY
Manufacturer
BIOSTRUCTURES, LLC
Date Cleared
2014-01-10
(191 days)
Product Code
MQV, MOV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
BIOSTRUCTURES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bioactive Bone Graft Putty is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Bioactive Bone Graft Putty is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine fusion procedures). Bioactive Bone Graft Putty can also be used with autograft as a bone graft extender in the posterolateral spine. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
Device Description
Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixture of calcium phosphate granules and bioactive glass granules suspended in a resorbable polymer carrier that facilitates handling and delivery of the granule components. The device is supplied as putty, pre-loaded in a syringe applicator and packaged in a sterile barrier foil pouch. The device is provided sterile, for single use, in a variety of sizes.
Ask a Question
K Number
K112857Device Name
INTERFACE BONE VOID FILLER
Manufacturer
BIOSTRUCTURES, LLC
Date Cleared
2011-12-13
(74 days)
Product Code
MQV, MOV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
BIOSTRUCTURES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Interface Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structures. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Interface Bone Void Filler is indicated to be gently packed into bony voids or gaps of the skeletal system (extremities and pelvis), or in the posterolateral spine when mixed with autograft. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Device Description
Interface Bone Void Filler is a synthetic bioactive bone graft for use in the repair of osseous defects. It is supplied as irregular synthetic granules of bioactive glass, sized from 200 microns to 420 microns. The elemental composition of Interface Bone Void Filler granules is Si, Ca. Na, and P. Interface Bone Void Filler conforms to ASTM specification F1538 for 45S5 bioactive glass.
Ask a Question
Page 1 of 1