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510(k) Data Aggregation
K Number
K234013Device Name
Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE
Manufacturer
Bone Solutions, Inc.
Date Cleared
2024-02-05
(48 days)
Product Code
MQV, OIS
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
Bone Solutions, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mg OSTEOINJECT™ is intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects or osseous defects created by traumatic injury to the bone.
Mg OSTEOINJECT™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.
Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.
Mg OSTEOINJECT™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOINJECT™ is resorbed and replaced with bone during the healing process.
Mg OSTEOINJECT™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Mg OSTEOREVIVE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects created by traumatic injury to the bone.
Mg OSTEOREVIVE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.
Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.
Mg OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOREVIVE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOREVIVE™ must be used with morselized autograft bone in the posterolateral spine.
When used in intervertebral body fusion procedures Mg OSTEOREVIVE™ must be used with morselized autograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mg OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Mg OSTEOCRETE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be tysts and tumors (in adults), may be surgically created osseous defects created by traumatic injury to the bone.
Mg OSTEOCRETE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.
Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.
Mg OSTEOCRETE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOCRETE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOCRETETM must be used with morselized autograft bone in the posterolateral spine.
When used in intervertebral body fusion procedures Mg OSTEOCRETE™ must be used with morselized autograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mg OSTEOCRETE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Device Description
The subject devices are a magnesium-based synthetic bone void filler that is moldable, injectable, drillable, adhesive/cohesive, radiopaque, and osteoconductive. The subject devices comprises a powder component (magnesium-based compound) and a mixing solution (buffered saline). Once the components are mixed intra-operatively prior to implantation, an acid-base reaction happens to form a cohesive paste. Once the product is placed into the bony void, the paste will adhere to the adjacent bone during the curing process. The devices are provided sterile to the end user for single-use only in various sizes from 3 cc to 15 cc.
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K Number
K221256Device Name
Mg OSTEOINJECT
Manufacturer
Bone Solutions, Inc.
Date Cleared
2022-06-28
(57 days)
Product Code
MQV, OIS
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
Bone Solutions, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mg OSTEOINJECT™ is intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. Mg OSTEOINJECT™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Mg OSTEOINJECT™ is intended to be placed into bony voids either before or after final fixation. Mg OSTEOINJECT™ is resorbed and replaced with bone during the healing process. Mg OSTEOINJECT™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Device Description
Mg OSTEOINJECT™ is a magnesium-based synthetic bone void filler that is drillable, resorbable, radiopaque, and osteoconductive. The Mg OSTEOINJECT™ Kit contains powder (magnesium-based compound) and a mixing solution (buffered saline). Once the components are mixed intra-operatively prior to implantation, an acid-base reaction happens to form a cohesive paste. Once the product is placed into the bony void, the paste will adhere to the adjacent bone during the curing process. The device is provided sterile to the end user for single-use only in two sizes, 3 cc and 5 cc.
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K Number
K212991Device Name
Osteorevive
Manufacturer
Bone Solutions, Inc.
Date Cleared
2022-01-21
(123 days)
Product Code
MQV, OIS
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
Bone Solutions, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OSTEOREVIVE™ is intended for bony voids or defects of the extremities, posterolateral spine, and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects created by traumatic injury to the bone. OSTEOREVIVE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation. OSTEOREVIVE™ is resorbed and replaced with bone during the healing process. OSTEOREVIVE™ must be used with morselized autograft bone at a ratio of 1:1 by volume in the posterolateral spine. OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Device Description
OSTEOREVIVE™ is a magnesium-based synthetic bone void filler that is drillable, resorbable, radiopaque, and osteoconductive. OSTEOREVIVE™ consists of a powder component and a liquid component (modified saline solution) that are mixed at the time of surgery. The powder components include ß-tricalcium phosphate, magnesium oxide, monopotassium phosphate, and monosodium phosphate. The mixing liquid is saline with monosodium phosphate. After mixing and setting OSTEOREVIVE™ is a non-porous solid material. OSTEOREVIVE™ is provided sterile to the end user in 5 cc, 10 cc, and 15 cc sizes.
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K Number
K192674Device Name
Mixing and Delivery System
Manufacturer
Bone Solutions, Inc.
Date Cleared
2020-02-18
(145 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Bone Solutions, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
Device Description
The Mixing and Delivery System is used to mix graft material such that it can be delivered to the patient. The system is comprised of the mixing/delivery syringe and auxiliary components including a threaded spindle with nut, open bore luer cap, pusher and cannulae which provide alternative methods of delivery for the mixed material.
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K Number
K161568Device Name
Bone Solutions Mixing and Delivery System
Manufacturer
BONE SOLUTIONS, INC.
Date Cleared
2016-09-16
(101 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
BONE SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bone Solutions Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
Device Description
The Bone Solutions Mixing and Delivery System is commercially available disposable medical piston syringe (syringe barrel with female luer, plunger) to facilitate mixing and a funnel to facilitate filling of the syringe barrel. The system with a 14 mL syringe barrel and will be provided empty.
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K Number
K071004Device Name
OSTEOCRETE BONE VOID FILLER
Manufacturer
BONE SOLUTIONS, INC.
Date Cleared
2009-05-21
(773 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
BONE SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bone Solutions. Inc., OsteoCrete™ Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Bone Solutions, Inc., OsteoCrete™ Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bone 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 void filler that resorbs and is replaced with bone during the healing process. OsteoCrete™ Bone Void Filler is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Device Description
OsteoCrete™ is an injectable, moldable, and biocompatible Bone Void Filler. The OsteoCrete™ Bone Void Filler Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.
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