Cleared Traditional

K261121 - Megalodon Dynamic Compression System

K261121 is an FDA 510(k) clearance for Megalodon Dynamic Compression System, manufactured by Paragon 28, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K261121 · Paragon 28, Inc. · Orthopedic device
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Aug 2026
Decision
125d
Days
Class 2
Risk

K261121 is an FDA 510(k) clearance for the Megalodon Dynamic Compression System. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Paragon 28, Inc. (Centennial, US). The FDA issued a Cleared decision on August 6, 2026 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Paragon 28, Inc. devices

FDA 510(k) Submission Details - K261121

510(k) Number K261121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2026
Decision Date August 06, 2026
Days to Decision 125 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
3d slower than avg
Panel avg: 122d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDR Staple, Fixation, Bone

All 154
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K261121.
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TMC Compression Implant System
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COGNiTiON™ Staple System
K240212 · Ortho Solutions UK , Ltd. · Feb 2024