DEN200035 is an FDA 510(k) submission for the BEAR (Bridge-Enhanced ACL Repair) Implant. This device is classified as a Resorbable Implant For Anterior Cruciate Ligament (acl) Repair (Class II - Special Controls, product code QNI).
Submitted by Miach Orthopaedics, Inc. (Westborough, US). The FDA issued a Not Cleared (DENG) decision on December 16, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3044. 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..
| 510(k) Number | DEN200035 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 04, 2020 |
| Decision Date | December 16, 2020 |
| Days to Decision | 195 days |
| Submission Type | Direct |
| Review Panel | Orthopedic (OR) |
| Summary | - |
| Product Code | QNI - Resorbable Implant For Anterior Cruciate Ligament (acl) Repair |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3044 |
| 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. |