Cleared Traditional

K242895 - Aevumed PHANTOM Suture Anchors (FDA 510(k) Clearance)

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

K242895 · Aevumed, Inc. · Orthopedic device
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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 590
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K242895.
ArthroTAK Tendon Anchor Kit
K252635 · ArthroTAK, LLC · May 2026
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
K260921 · Tigon Medical · Apr 2026
Arthrex FiberTak Suture Anchor
K260561 · Arthrex, Inc. · Mar 2026
Grappler Suture Anchor PCFD Tether System
K253886 · Paragon 28, Inc. · Mar 2026
SINEFIX
K254176 · BAAT Medical Products B.V. · Mar 2026
Trax EX Anchor
K251750 · Trax Surgical, Inc. · Mar 2026