Cleared Traditional

K231231 - MR Safety and Compatibility Testing and...

K231231 is the FDA 510(k) clearance for MR Safety and Compatibility Testing and... by Paragon 28, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K231231 · Paragon 28, Inc. · Orthopedic device
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Oct 2023
Decision
167d
Days
Class 2
Risk

K231231 is an FDA 510(k) clearance for the MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fi.... Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on October 12, 2023 after a review of 167 days - an extended review 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: 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

Submission Details

510(k) Number K231231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2023
Decision Date October 12, 2023
Days to Decision 167 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
45d slower than avg
Panel avg: 122d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 563
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K231231.
Zimed Distal Medial Tibial Plate and Screw System
K230507 · Zimed Medikal · Jan 2024
Cannulated Screw System
K233396 · Smith & Nephew, Inc. · Dec 2023
APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension
K232251 · Medartis AG · Nov 2023
Intraosseous Fusion Device System
K231649 · Auxano Medical, LLC · Sep 2023
Accelerate Compression Screw System-Small Product Code ACC-S
K230946 · Trax Surgical · Sep 2023
TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System
K231504 · Vilex, LLC · Sep 2023