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510(k) DEN200035

BEAR (Bridge-Enhanced ACL Repair) Implant by Miach Orthopaedics, Inc. — Product Code QNI

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
December 16, 2020
Date Received
June 4, 2020
Clearance Type
Direct
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.

Other clearances by Miach Orthopaedics, Inc.

  • K251214 — BEAR® (Bridge-Enhanced ACL Restoration) Implant (January 13, 2026)
  • K243578 — BEAR® (Bridge-Enhanced ACL Restoration) Implant (March 6, 2025)

Other clearances for product code QNI

  • K251214 — BEAR® (Bridge-Enhanced ACL Restoration) Implant (January 13, 2026)
  • K243578 — BEAR® (Bridge-Enhanced ACL Restoration) Implant (March 6, 2025)