Cleared Traditional

K243578 - BEAR® (Bridge-Enhanced ACL Restoration) Implant (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence.

K243578 · Miach Orthopaedics, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2025
Decision
107d
Days
Class 2
Risk

K243578 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 March 6, 2025 after a review of 107 days - within the typical 510(k) review window.

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 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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 122d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. 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.

Clinical Evidence

ClinicalTrials.gov
NCT03348995 Active not recruiting Interventional Industry-sponsored

The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration

A Prospective Cohort Clinical Trial Evaluating Age as a Risk Factor for Poor Outcomes of Bridge-Enhanced ACL Restoration (BEAR)

250
Patients (est.)
11
Sites
Treatment
Purpose
Open label
Masking
Condition studied Anterior Cruciate Ligament Injury; Anterior Cruciate Ligament Rupture
Study design Single group
Eligibility All sexes · 12 Years+
Sponsor Miach Orthopaedics (industry)
Started 2018-04-17 → Primary completion 2026-01-31 → Completed 2034-04-17
Primary outcome
International Knee Documentation Committee Subjective Score (IKDC) (Survey)
Secondary outcome
Knee Injury and Osteoarthritis Score (KOOS) questionnaire
View full study on ClinicalTrials.gov