Not Cleared Direct

DEN200035 - BEAR (Bridge-Enhanced ACL Repair) Implant (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN200035 · Miach Orthopaedics, Inc. · Orthopedic device
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Dec 2020
Decision
195d
Days
Class 2
Risk

DEN200035 is an FDA 510(k) submission (not cleared) for the BEAR (Bridge-Enhanced ACL Repair) Implant. Classified as Resorbable Implant For Anterior Cruciate Ligament (acl) Repair (product code QNI), Class II - Special Controls.

Submitted by Miach Orthopaedics, Inc. (Westborough, US). The FDA issued a Not Cleared (DENG) decision on December 16, 2020 after a review of 195 days.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3044 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Orthopedic review framework.

View all Miach Orthopaedics, Inc. devices

Submission Details

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 122d · This submission: 195d
Pathway characteristics

Device Classification

Product Code QNI Resorbable Implant For Anterior Cruciate Ligament (acl) Repair
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.