Cleared Traditional

K234128 - Phantom Fibula Nail System

K234128 is the FDA 510(k) clearance for Phantom Fibula Nail System by Paragon 28, Inc.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K234128 · Paragon 28, Inc. · Orthopedic device
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Aug 2024
Decision
238d
Days
Class 2
Risk

K234128 is an FDA 510(k) clearance for the Phantom Fibula Nail System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on August 22, 2024 after a review of 238 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 K234128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2023
Decision Date August 22, 2024
Days to Decision 238 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
116d slower than avg
Panel avg: 122d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 318
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K234128.
Atlas™ Humeral Nail System
K241484 · Orthopedic Designs North America, Inc. (Odi-Na) · Nov 2024
Affixus Tibial and Antegrade Femoral Nailing System
K241651 · Zimmer, Inc. · Sep 2024
Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System
K230071 · Tdm Co., Ltd. · Aug 2024
DePuy Synthes Retrograde Femoral Nail Advanced System
K233696 · DePuy Synthes · Aug 2024
Fitbone Trochanteric
K233867 · Orthofix Srl · Jun 2024
RODEO Telescopic Nail
K232648 · Orthofix Srl · May 2024