K243578 is an FDA 510(k) clearance for the BEAR® (Bridge-Enhanced ACL Restoration) 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 Cleared decision on March 6, 2025, 107 days after receiving the submission on November 19, 2024.
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 | K243578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2024 |
| Decision Date | March 06, 2025 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| 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. |