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CERAMENT G is a resorbable, gentamic bone void filler intended for use in defects in the extremntes of skeletally mature patients as an adjunct to systemic antibiotic therapy and surgical debridement as part of the standard treatment approach to bone infection and open fractures. By eluting gentamicin, CERAMENT G can reduce the occurrence of bone infection from gentamicinsensitive microorganisms in order to protect bone healing. CERAMENT G can augment provisional hardware to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. CERAMENT G resorbs and is replaced by bone during the healing process.

CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) where there is a need for supplemental bone graft. It is composed of hydroxyapatite, calcium sulfate and gentamicin, and is identical to the device cleared in DEN210044. This submission expands the device's indication to include use in patients with open fractures in need for bone void filling.

CERAMENT BONE VOID FILLER is a ceramic bone graft substitute intended for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. CERAMENT BONE VOID FILLER is indicated to be injected, or placed, into bony voids or gaps in the skeletal system, i.e. extremities, pelvis, posterolateral spine (only during open surgery in spine), and intervertebral disc space. These defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 9 years old), or osseous defects created as a result of either surgery or traumatic injury to the bone. When used in intervertebral body fusion procedures, CERAMENT BONE VOID FILLER must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler. CERAMENT BONE VOID FILLER resorbs and is replaced by bone during the healing process. CERAMENT BONE VOID FILLER can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. CERAMENT BONE VOID FILLER can be drilled and screws can be placed through it.

CERAMENT BONE VOID FILLER is composed of hydroxyapatite, calcium sulfate hemihydrate, and calcium sulfate dihydrate, and it identical to the device cleared in K201535. This submission expands the device's indication to include use in the intervertebral space.

CERAMENT | BONE VOID FILLER is a ceramic bone graft substitute intended for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. CERAMENT | BONE VOID FILLER is indicated to be injected, or placed, into bony voids or gaps in the skeletal system, i.e. extremities, pelvis, and posterolateral spine (only during open surgery in spine). These defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 9 years old), or osseous defects created as a result of either surgery or traumatic injury to the bone. CERAMENT | BONE VOID FILLER resorbs and is replaced by bone during the healing process. CERAMENT | BONE VOID FILLER can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. CERAMENT | BONE VOID FILLER can be drilled and screws can be placed through it.

CERAMENT| BONE VOID FILLER is a fast-setting, injectable and moldable ceramic bone graft substitute intended for filling bone voids/gaps. The material consists of a powder and a liquid component. The major constituents of the powder are hydroxyapatite and calcium sulfate hemihydrate. The liquid component (C-TRU) contains iohexol as a radio-opacification enhancer. Mixing the components with the combined mixing injection (CMI) device, results in a viscous material intended to set ex vivo or in vivo. By combining hydroxyapatite and calcium sulfate, an optimal balance is achieved between implant resorption rate and bone ingrowth rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate, high osteoconductivity, promoting bone ingrowth and gives long term structural support to the newly formed bone. The ceramic bone graft substitute is placed into the bone defect under direct visualization or under radiographic monitoring during open or percutaneous surgery. The paste may be injected into the defect, molded by hand and digitally placed into the defect, or used to prepare beads that are placed into the defect. The accompanying injection device (ID) and Tip Extenders may be used to facilitate filling the bone defect. When fully set in vivo, CERAMENT | BONE VOID FILLER is drillable and can be used to augment hardware during the surgical procedure.

CERAMENT™|BONE VOID FILLER is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. CERAMENT™|BONE VOID FILLER is indicated to be injected into bony voids or gans in the skeletal system, i.e. extremities, pelvis and spine (only during open surgery in spine). These defect smav he surgically created osseous defects or osseous defects from traumatic injury to the bone. CERAMENT™ (BONE VOID FILLER provides a bone void filler that resorbs and is replaced by bone during the healing process.

CERAMENT™|BONE VOID FILLER is an injectable ceramic bone substitute material intended for bone voids/gaps. The material consists of a powder and a liquid component. The major constituents of the powder are calcium sulfate and hydroxyapatite. The liquid component contains iohexol as a radio-opacity enhancer. Mixing the components, with the combined mixing injection device, results in a viscous material suitable for injection into a bone void/gap. During resorption of the calcium sulfate dihydrate, the hydroxyapatite remains intact providing osteoconductive support for in-growth of new bone. The ceramic bone substitute material is injected into the bone void/gap, under visual inspection or under radiographic monitoring, with the use of the accompanying injection devices.

CERAMENT™|BONE VOID FILLER is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. CERAMENT™|BONE VOID FILLER is indicated to be injected into bony voids or gaps in the skeletal system, i.e. extremities, pelvis and spine (only during open surgery in spine). These defects may be surgically created osseous defects or osseous defects from traumatic injury to the bone. CERAMENT™|BONE VOID FILLER provides a bone void filler that resorbs and is replaced by bone during the healing process. CERAMENT™|BONE VOID FILLER is not intended for use in load bearing applications such as vertebroplasty or kyphoplasty.

CERAMENT™|BONE VOID FILLER is an injectable ceramic bone substitute material intended for bone voids. The material consists of a powder and a liquid component. The major constituents of the powder are calcium sulfate hemihydrate and sintered hydroxyapatite. The liquid component contains iohexol as a radio-opacity enhancer. Mixing the components, with the combined mixing injection device, results in a viscous material suitable for percutaneous injection into a bone void. During resorption of the calcium sulfate dihydrate, the hydroxyapatite remains intact providing osteoconductive support for in-growth of new bone. The ceramic bone substitute material is injected into the bone void in a percutaneous procedure, under visual inspection or under radiographic monitoring, with the use of the accompanying injection device.