Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
Medical specialty
Orthopedic
Device class
2
Regulation number
888.3044
Review panel
OR
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
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.