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Found 28 results
510(k) Data Aggregation
K Number
K241027Device Name
Permatage Settable Bone Putty
Manufacturer
Orthocon, Inc.
Date Cleared
2024-09-26
(164 days)
Product Code
GXP
Regulation Number
882.5300Why did this record match?
Applicant Name (Manufacturer) :
Orthocon, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orthocon Permatage Settable Bone Putty is a self-setting cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects. Permatage Settable Bone Putty should be used only in skeletally mature individuals.
Device Description
Permatage Settable Bone Putty is a sterile, biocompatible, nonabsorbable material of putty-like consistency for use in repair of cranial defects. The single use Permatage device contains two separate components of putty-like consistency comprised of granular calcium phosphate, paraffin oil, vitamin E acetate, a triglyceride, and a mixture of nonabsorbable, polyether-based polymers. When mixed together, the components of the Permatage device form a nonabsorbable cohesive, putty-like material that adheres to the bone surface and remains in place following application. The resulting hardening material is primarily calcium phosphate and nonabsorbable polymer materials. Permatage components must be mixed immediately prior to use.
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K Number
K233566Device Name
Montage-XT Settable, Resorbable Bone Putty
Manufacturer
Orthocon, Inc.
Date Cleared
2024-08-21
(289 days)
Product Code
MQV, MTJ, OIS
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
Orthocon, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orthocon Montage-XT Settable, Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These defects may be surgically created, or osseous defects created as the result of traumatic injury to the bone. Montage-XT is indicated only for filling bony voids or gaps that are not intrinsic to the integrity of the bony structure.
When hardened in situ, Montage-XT may be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surgical procedure. The hardened putty acts only as a temporary support medium and is not intended to provide structural support during the healing process.
Montage-XT can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
Device Description
Montage-XT Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in filling bony voids or gaps in skeletal bones of the extremities. The single use Montage-XT device contains two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyesterbased polymers. When mixed together, the components of Montage-XT form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened material is primarily calcium phosphate. Montage-XT can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
Montage-XT differs from Montage by allowing for an extended working time of up to 4 minutes.
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K Number
K232771Device Name
Montage Flowable Settable, Resorbable Bone Paste
Manufacturer
Orthocon, Inc.
Date Cleared
2024-02-16
(158 days)
Product Code
GXP
Regulation Number
882.5300Why did this record match?
Applicant Name (Manufacturer) :
Orthocon, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orthocon Montage Flowable Settable Bone Paste is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous cranial defects with a surface area no larger than 25cm2. Montage Flowable Settable, Resorbable Bone Paste should be used only in skeletally mature individuals.
Device Description
Montage Flowable Settable, Resorbable Bone Paste is a sterile, biocompatible, resorbable material for use in repair of cranial defects. The Montage Flowable device comprises two separate components of putty consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the Montage Flowable device form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate. Montage Flowable components must be mixed immediately prior to use.
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K Number
K231475Device Name
MONTAGE-QS Settable, Resorbable Bone Putty
Manufacturer
Orthocon, Inc.
Date Cleared
2023-10-12
(143 days)
Product Code
GXP
Regulation Number
882.5300Why did this record match?
Applicant Name (Manufacturer) :
Orthocon, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orthocon MONTAGE-OS Settable Bone Putty is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous cranial defects with a surface area no larger than 25cm². MONTAGE-QS Settable, Resorbable Bone Putty should be used only in skeletally mature individuals.
Device Description
MONTAGE-QS Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in repair of cranial defects. The MONTAGE-QS device comprises two separate components of putty consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyesterbased polymers. When mixed together, the components of the MONTAGE-QS device form a putty-like material. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE-QS components must be mixed immediately prior to use.
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K Number
K232998Device Name
Montage- XT Settable, Resorbable Hemostatic Bone Putty
Manufacturer
Orthocon, Inc.
Date Cleared
2023-10-12
(20 days)
Product Code
MTJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Orthocon, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Montage-XT Settable, Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries. Montage-XT is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
Device Description
MONTAGE-XT Settable. Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use MONTAGE-XT device contains two separate components of putty-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE-XT device form a resorbable putty-like material that can be applied directly to bleeding bone. The resulting hardening material is primarily comprised of calcium phosphate. MONTAGE-XT must be mixed immediately prior to use.
When applied to surgically cut or traumatically broken bone, MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).
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K Number
K231270Device Name
Montage Flowable Settable, Resorbable Bone Paste
Manufacturer
Orthocon, Inc.
Date Cleared
2023-09-01
(122 days)
Product Code
MQV, MOV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
Orthocon, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orthocon MONTAGE Flowable Settable, Resorbable Bone Paste is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These defects may be surgically created or osseous defects created as the result of traumatic injury to the bone. Montage Flowable is indicated only for filling bony voids or gaps that are not intrinsic to the integrity of the bony structure.
When hardened in situ, Montage Flowable may be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surgical procedure. The hardened paste acts only as a temporary support medium and is not intended to provide structural support during the healing process.
Montage Flowable can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
Device Description
Montage Flowable Settable. Resorbable Bone Paste is a sterile. biocompatible, resorbable material for use in filling bony voids or gaps in skeletal bones of the extremities. The Montage Flowable device comprises two separate components of paste-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together in the applicator tip, the components of the Montage Flowable device form a cohesive paste-like material that adheres to the bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate and is slowly resorbed and replaced with bone during the remodeling process. Montage Flowable can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
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K Number
K213418Device Name
MONTAGE Settable, Resorbable Hemostatic Bone Putty
Manufacturer
Orthocon, Inc.
Date Cleared
2023-08-30
(679 days)
Product Code
MTJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Orthocon, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MONTAGE Settable, Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries. MONTAGE is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
Device Description
MONTAGE Settable. Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. The MONTAGE device comprises two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE device form a cohesive putty-like material that adheres to the bleeding bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE components must be mixed immediately prior to use. When applied to surgically cut or traumatically broken bone, MONTAGE Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).
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K Number
K231903Device Name
Montage-QS Settable, Resorbable Bone Putty
Manufacturer
Orthocon, Inc.
Date Cleared
2023-08-25
(58 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
Orthocon, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orthocon Montage-QS Settable, Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These defects may be surgically created, or osseous defects created as the result of traumatic injury to the bone. Montage-QS is indicated only for filling bony voids or gaps that are not intrinsic to the integrity of the bony structure.
When hardened in situ, Montage-QS may be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surgical procedure. The hardened putty acts only as a temporary support medium and is not intended to provide structural support during the healing process.
Montage-QS can be drilled and tapped, and hardware can be placed through it at any time during process.
Device Description
Montage-QS Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in filling bony voids or gaps in skeletal bones of the extremities. The Montage-QS device comprises two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the Montage-QS device form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate and is slowly resorbed and replaced with bone during the remodeling process. Montage-QS can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
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K Number
K231386Device Name
Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste
Manufacturer
Orthocon, Inc.
Date Cleared
2023-07-11
(60 days)
Product Code
MTJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Orthocon, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
Device Description
Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. The single use device contains two separate components of paste-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols, a mixture of a lactide-diester and polyester-based polymers and barium sulfate. When mixed together, the components of the device form a resorbable paste-like material that can be applied directly to bleeding bone by means of a single-use applicator (delivery device). The resulting hardening paste is primarily comprised of calcium phosphate. Montage Flowable XRO is mixed immediately prior to use.
When applied to surgically cut or traumatically broken bone. Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste achieves local control of bleeding by acting as a mechanical barrier (tamponade).
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K Number
K222063Device Name
MONTAGE Settable, Resorbable Bone Putty
Manufacturer
Orthocon, Inc.
Date Cleared
2023-02-03
(205 days)
Product Code
MQV, OIS
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
Orthocon, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orthocon MONTAGE Settable, Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (i.e. extremities and pelvis). These defects may be surgically created, or osseous defects created as the result of traumatic injury to the bone. MONTAGE is indicated only for filling bony voids or gaps that are not intrinsic to the integrity of the bony structure.
When hardened in situ, MONTAGE may be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surgical procedure. The hardened putty acts only as a temporary support medium and is not intended to provide structural support during the healing process.
MONTAGE can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
Device Description
MONTAGE Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in filling bony voids or gaps in skeletal bones of the extremities. The MONTAGE device comprises two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE device form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened material is primarily calcium phosphate. MONTAGE components must be mixed immediately prior to use. MONTAGE can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
Ask a Question
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