FDA Product Code QNI: 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.
Leading manufacturers include Miach Orthopaedics, Inc..
FDA 510(k) Cleared Resorbable Implant For Anterior Cruciate Ligament (acl) Repair Devices (Product Code QNI)
About Product Code QNI - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QNI since 2020, with 2 receiving FDA clearance (average review time: 191 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for QNI submissions have been consistent, averaging 189 days recently vs 195 days historically.
QNI devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →