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510(k) Data Aggregation
K Number
K243609Device Name
EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )
Manufacturer
ETEX Corporation
Date Cleared
2024-12-18
(26 days)
Product Code
MQV, MBP
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
ETEX Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EquivaBone is a bone graft substitute that combines synthetic calcium phosphate and demineralized bone. It is resorbed and replaced with new bone during the healing process. It is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine) 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 from traumatic injury to the bone.
Device Description
EquivaBone is a biocompatible bone graft substitute material consisting of Calcium Phosphate (CaP3), Carboxymethylcellulose (CMC) and Demineralized Bone Matrix (DBM). EquivaBone is supplied in a single use kit as sterile powders and hydration that are mixed together at the time of use in the operating room to form flowable putty which is implanted manually or can be extruded through a syringe. After implantation the product hardens at body temperature and remodels during the healing process.
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K Number
K182107Device Name
CarriGen PF
Manufacturer
ETEX Corporation
Date Cleared
2018-08-31
(28 days)
Product Code
MQV, FMF
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
ETEX Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteo-conductive, 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 bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
Device Description
CarriGen Porous Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. CarriGen PF is a mixing syringe pre-filled with the previously cleared CarriGen Porous Bone Substitute Material. The CarriGen PF system eliminates the need to transfer the CarriGen powder to the mixing syringe. After mixing, CarriGen is administered to the treatment site by manual application. The material can be shaped into a desired form in situ prior to implantation. After the putty is applied to the treatment site, it 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. CarriGen Porous Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
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K Number
K132868Device Name
CARRICELL
Manufacturer
ETEX CORPORATION
Date Cleared
2015-02-20
(525 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
ETEX CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CarriCell® is indicated for filling bone voids or defects of the sketal system (i.e., extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. CarriCell® may be hydrated with saline or autologous blood prior to implantation. CarriCell® is a bone graft substitute that resorbs and is replaced with new bone during process.
Device Description
CarriCell® 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 solution to form a putty. No mixing is required. The putty can be administered to the treatment site by syringe or manual application. The material can be shaped into a desired form prior to implantation. After the putty is applied to the treatment site, it 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 chemical and crystalline structure similar to that of natural bone minerals. CarriCell® Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
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K Number
K141245Device Name
ETEX MIXING AND DELIVERY SYSTEM
Manufacturer
ETEX CORPORATION
Date Cleared
2014-07-09
(56 days)
Product Code
FMF, IND
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
ETEX CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ETEX 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 ETEX Mixing and Delivery System is comprised of a commercially available disposable medical piston syringe (syringe barrel with female luer, plunger). The ETEX Mixing and Delivery System is provided sterile, for single use only.
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K Number
K102812Device Name
GAMMA-BSM; BETA-BSM; EQUIVABONE
Manufacturer
ETEX CORPORATION
Date Cleared
2010-12-03
(66 days)
Product Code
LYC, NUN
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
ETEX CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Beta-bsm Injectable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects 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. Beta-bsm Injectable Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Gamma-bsm Moldable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects 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. Gamma-bsm Moldable Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
EquivaBone Osteoinductive Bone Graft Substitute is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix combined with demineralized bone matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects 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. EquivaBone Osteoinductive Bone Graft Substitute is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Device Description
Beta-bsm Injectable 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 mixing solution and mixed to form a paste. Mixing is facilitated by a syringe-to-syringe mixing system. The resulting paste can be administered to the treatment site under direct visualization using the syringe or manual application. The material can be shaped into a desired form in-situ prior to implantation. After the paste is applied to the treatment site, it 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. Beta-bsm Injectable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
Gamma-bsm Moldable 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 mixing solution and mixed to form a putty. The resulting putty is administered to the treatment site by manual application. The material can be shaped into a desired form in-situ prior to implantation. After the putty is applied to the treatment site, it 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. Gamma-bsm Moldable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
EquivaBone is a biocompatible bone graft substitute material consisting of synthetic calcium phosphate, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). It is supplied in a single use kit as sterile powders and hydration solution that are mixed together at the time of use in the operating room to form flowable putty which is implanted manually or can be extruded through a syringe. After implantation the product hardens at body temperature and resorbs and remodels during the healing process. Each lot of DBM contained within EquivaBone is assayed for osteoinductive potential in an athymic nude mouse model. This may or may not be predictive of EquivaBone osteoinductivity in humans.
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