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BEAR Implant (Bridge-Enhanced ACL Restoration)
Resorbable implant for anterior cruciate ligament (ACL) repair. A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.
Details
Device typeJoint cartilage biomatrix implant: A bioabsorbable animal-derived material intended to be implanted in the void of a cartilage defect of a joint (e.g., knee, ankle, shoulder), typically up to a diameter of 34 mm, during an orthopaedic or traumatologic intervention, to promote the ingrowth of autologous cells (e.g., with bone marrow stimulation techniques) for cartilage reconstruction or augmentation. It consists primarily of an animal-derived matrix structure (e.g., made of animal-derived type 1 collagen, chitosan) that provides a scaffold for cell growth. It is available in various dimensions or may be an injectable fluid, and can be applied arthroscopically, or with miniarthrotomy for larger defects.
FDA categoryResorbable Implant For Anterior Cruciate Ligament (Acl) Repair
Device ID00860002987804
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information