Cleared Traditional

K251214 - BEAR® (Bridge-Enhanced ACL Restoration) Implant (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251214 · Miach Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
270d
Days
Class 2
Risk

K251214 is an FDA 510(k) clearance for the BEAR® (Bridge-Enhanced ACL Restoration) 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 Cleared decision on January 13, 2026 after a review of 270 days - an extended review cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Miach Orthopaedics, Inc. devices

Submission Details

510(k) Number K251214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2025
Decision Date January 13, 2026
Days to Decision 270 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 122d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Consultant

Broderick Regulatory Consulting, LLC
Julie Broderick

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.