Cleared Traditional

K242895 - Aevumed PHANTOM Suture Anchors

K242895 is the FDA 510(k) clearance for Aevumed PHANTOM Suture Anchors by Aevumed, Inc.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K242895 · Aevumed, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
317d
Days
Class 2
Risk

K242895 is an FDA 510(k) clearance for the Aevumed PHANTOM Suture Anchors. 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 August 6, 2025 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Aevumed, Inc. devices

Submission Details

510(k) Number K242895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2024
Decision Date August 06, 2025
Days to Decision 317 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
195d slower than avg
Panel avg: 122d · This submission: 317d
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
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K242895.
Aevumed FASE Suture Anchor
K253040 · Aevumed, Inc. · Oct 2025
Mini Superhawk Suture Anchor System
K253010 · Responsive Arthroscopy, LLC · Oct 2025
All-Suture Dual Anchor System
K250095 · Suturetech, Inc. · Sep 2025
Iconix Speed Anchor
K252144 · Riverpoint Medical · Jul 2025
OTS 25-L (100-5)
K251310 · Ots Medical , Ltd. · Jul 2025
Arthrex FiberTak Suture Anchor
K251809 · Arthrex, Inc. · Jul 2025