• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device resorbable implant for anterior cruciate ligament (acl) repair
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.
Physical State The device is a gel, moldable solid, or rigid solid that is resorbable.
Technical Method The device is intended to protect the biological healing process from the surrounding intraarticular environment and not to replace biomechanical fixation via suturing.
Target Area Knee (ACL)
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeQNI
Premarket Review Orthopedic Devices (OHT6)
Stereotaxic, Trauma and Restorative Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.3044
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-