Cleared Special

K240530 - DynaNail Mini Tapered Hybrid

K240530 is the FDA 510(k) clearance for DynaNail Mini Tapered Hybrid by MedShape, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Special 510(k) pathway after a 27-day FDA review.

K240530 · MedShape, Inc. · Orthopedic device
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Mar 2024
Decision
27d
Days
Class 2
Risk

K240530 is an FDA 510(k) clearance for the DynaNail Mini Tapered Hybrid. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by MedShape, Inc. (Atlanta, US). The FDA issued a Cleared decision on March 21, 2024 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all MedShape, Inc. devices

Submission Details

510(k) Number K240530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2024
Decision Date March 21, 2024
Days to Decision 27 days
Submission Type Special
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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 K240530.
OSSIOfiber® Threaded Trimmable Fixation Nail
K241277 · OSSIO , Ltd. · Jul 2024
Arthrex Cannulated Screw System
K240815 · Arthrex, Inc. · Jun 2024
Cannulated Headless Bone Screws
K233008 · Aap Implantate AG · Jun 2024
ARIX Cannulated Screw System
K233912 · Jeil Medical Corporation · Mar 2024
OSSIOfiber® Threaded Trimmable Fixation Nails
K233198 · OSSIO , Ltd. · Mar 2024
SnapHammer Hammertoe Correction System
K231453 · Nvision Biomedical Technologies, Inc. · Feb 2024