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510(k) Data Aggregation
K Number
K242302Device Name
RejuvaKnee Collagen Meniscus Implant
Manufacturer
Collagen Matrix, Inc.
Date Cleared
2024-10-02
(58 days)
Product Code
OLC
Regulation Number
878.3300Why did this record match?
Product Code :
OLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RejuvaKnee is intended for use in surgical procedures for the reinforcement and repair of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the RejuvaKnee must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.
RejuvaKnee reinforces soft tissue and provides a reasonable scaffold that is replaced by the patient's own soft tissue. The RejuvaKnee is not a prosthetic device and is not intended to replace normal body structure.
Device Description
The RejuvaKnee™ Collagen Meniscus Implant is comprised primarily of bovine Type I collagen (nominally 99%) derived from meniscus. The device is provided in a semi-lunar shape with a triangular cross section to be used to reinforce weakened soft tissue and provide a resorbable scaffold that is replaced by the patient's own tissue.
RejuvaKnee is supplied sterile and is intended for single use.
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K Number
K170364Device Name
Collagen Meniscus Implant XL
Manufacturer
Ivy Sports Medicine, LLC
Date Cleared
2017-05-02
(85 days)
Product Code
OLC
Regulation Number
878.3300Why did this record match?
Product Code :
OLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ivy Sports Medicine Collagen Meniscus Implant (CMI) is intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus. In repairing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the CMI must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.
The CMI reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue. The CMI is not a prosthetic device and is not intended to replace normal body structure.
Device Description
The Ivy Sports Medicine Collagen Meniscus Implant XL (CMI XL) is a resorbable collagen matrix comprised primarily of bovine type I collagen. The CMI is provided in a semi-lunar shape with a triangular cross section to be used to reinforce weakened soft tissue and provide a resorbable scaffold that is replaced by the patient's own tissue. The surgeon trims the device to the size necessary for repair of the damaged or weakened soft tissue. The CMI XL is provided sterile for single use only.
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K Number
K082079Device Name
REGEN COLLAGEN SCAFFOLD (CS)
Manufacturer
REGEN BIOLOGICS, INC.
Date Cleared
2008-12-18
(148 days)
Product Code
OLC
Regulation Number
878.3300Why did this record match?
Product Code :
OLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ReGen Collagen Scaffold (CS) is intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the CS must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.
The CS reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue. The CS is not a prosthetic device and is not intended to replace normal body structure.
Device Description
The ReGen Collagen Scaffold (CS) is a resorbable collagen matrix comprised primarily of bovine type I collagen. The CS is provided in a semi-lunar shape with a triangular cross section to be used to reinforce weakened soft tissue and provide a resorbable scaffold that is replaced by the patient's own tissue. The surgeon trims the device to the size necessary for repair of the damaged or weakened soft tissue.
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