Cleared Traditional

K254306 - Aevumed FENIX Suture Anchor

K254306 is the FDA 510(k) clearance for Aevumed FENIX Suture Anchor by Aevumed, Inc.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K254306 · Aevumed, Inc. · Orthopedic device
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Mar 2026
Decision
63d
Days
Class 2
Risk

K254306 is an FDA 510(k) clearance for the Aevumed FENIX Suture Anchor. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Aevumed, Inc. (Malvern, US). The FDA issued a Cleared decision on March 4, 2026 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aevumed, Inc. devices

Submission Details

510(k) Number K254306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2025
Decision Date March 04, 2026
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 412
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