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510(k) Data Aggregation
K Number
K190814Device Name
AccuFill Bone Substitute Material
Manufacturer
Date Cleared
2019-06-10
(73 days)
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
Zimmer Knee Creations
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AccuFill Bone Substitute Material is an injectable, seff-setting, macroporous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e., posterolateral spine), and the pelvis 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. AccuFill BSM is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
Device Description
AccuFill Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of hydration fluid and mixed. Once mixed, the resulting paste is used to fill osseous defects. The paste can be administered to the treatment site by injection or by manual application. AccuFill hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite ("PCHA"), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. AccuFill is an osteoconductive material that is resorbed and replaced by natural bone over time.
AccuFill BSM is available in two packaging configurations: (1) AccuFill BSM is sold in a jar and can be mixed in a bowl or mixing syringe; (2) AccuFill BSM is also sold in a prefilled mixing syringe. AccuFill BSM is delivered to the osseous defect site with stainless steel AccuPort cannulas.
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K Number
K133021Device Name
MIXING SYRINGE SYSTEM
Manufacturer
Date Cleared
2014-01-13
(109 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
ZIMMER KNEE CREATIONS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Mixing Syringe 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 Syringe System is comprised of a commercially available disposable medical piston syringe (syringe barrel with female luer, plunger), and mixing system funnel. The Mixing Syringe System is provided sterile, for single use only.
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