Cleared Traditional

K230257 - Arthrex Intramedullary Nails

K230257 is the FDA 510(k) clearance for Arthrex Intramedullary Nails by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K230257 · Arthrex, Inc. · Orthopedic device
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Jul 2023
Decision
167d
Days
Class 2
Risk

K230257 is an FDA 510(k) clearance for the Arthrex Intramedullary Nails. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on July 17, 2023 after a review of 167 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Arthrex, Inc. devices

Submission Details

510(k) Number K230257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2023
Decision Date July 17, 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 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 322
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K230257.
Precice Ankle Salvage System
K230765 · Nuvasive Specialized Orthopedics, Inc. · Aug 2023
Pediatric Nailing Platform Tibia
K231266 · OrthoPediatrics Corp. · Aug 2023
Zimmer® Natural Nail® System Cephalomedullary Nails
K231114 · Zimmer Switzerland Manufacturing GmbH · Aug 2023
SGM Femoral Nail System
K230456 · Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. · Jun 2023
Gamma4 System
K230512 · Stryker GmbH · Jun 2023
Precice Intramedullary Limb Lengthening System
K220234 · Nuvasive Specialized Orthopedics, Inc. · Mar 2023