510(k) K251214
K251214 is an FDA 510(k) premarket notification submitted by Miach Orthopaedics, Inc. for the device "BEAR® (Bridge-Enhanced ACL Restoration) Implant". The FDA issued a decision of Substantially Equivalent on January 13, 2026. The device falls under product code QNI (Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair), a Class II device regulated under 21 CFR 888.3044. Miach Orthopaedics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 2026
- Date Received
- April 18, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
- Device Class
- Class II
- Regulation Number
- 888.3044
- Review Panel
- OR
- Submission Type
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.