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510(k) Data Aggregation
K Number
K123225Device Name
BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60
Manufacturer
AAP BIOMATERIALS GMBH & CO. KG
Date Cleared
2013-03-15
(151 days)
Product Code
LOD
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
**AAP BIOMATERIALS GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BonOs R is intended for use in arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
Device Description
BonOs R is a fast-setting acrylic resin for use in bone surgery. The bone cement is made of two separate sterile components. When both cement components are mixed together, they become a self hardening, radlopaque bone cement which fixes the implant and transfers stressesevenly to the bone.
Bone cements in general are self-polymerizing two-component systems comprising a powder and a liquid which polymerize at room temperature immediately after they are mixed together.
The major powder component is polymethyl methacrylate / acrylate. Furthermore a radio-opacifier and benzoyl peroxide as an initiator is Included.
The liquid mainly consists of methyl methacrylate. It is furthermore comprised of an activator and a stabilizer to prevent premature polymerization.
When the powder and liquid components are mixed together, the activator, DmpT, contained in the liquid activates the initiator in the powder component. This reaction starts the polymerization of the MMA, which is bonded with the polymer powder during ongoing polymerization. A description of polymerization technology is depictured in section 10- Executive summary, annex 10 - A.
As a result, a viscous paste is obtained which can be introduced into bone using a suitable application system. Heat is generated during setting as a result of the progressive polymerization and exothermlc reaction respectively. After curing, the bone cement is able to fix the implant. The setting or curing time is greatly influenced by the temperature of the components and environment, which Is common for all acrylic bone cements.
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K Number
K123081Device Name
BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40
Manufacturer
AAP BIOMATERIALS GMBH & CO. KG
Date Cleared
2013-03-07
(157 days)
Product Code
LOD, MBB
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
**AAP BIOMATERIALS GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BonOs R Genta is intended for use in arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second stage of a two-stage revision after the initial infection has been cleared.
Device Description
BonOs R Genta is a fast-setting acrylic resin with the addition of gentamicin sulfate for use in bone surgery. The bone cement is made of two separate sterile components. When both cement components are mixed together, they become a self hardening, radiopaque bone cement which fixes the implant and transfers stresses evenly to the bone.
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