Cleared Special

Medline UNITE Jones Fracture Screw System (K201319) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K201319 · Medline Industires, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jun 2020
Decision
30d
Days
Class 2
Risk

K201319 is an FDA 510(k) clearance for the Medline UNITE Jones Fracture Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Medline Industires, Inc. (Northfield, US). The FDA issued a Cleared decision on June 17, 2020 after a review of 30 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 Medline Industires, Inc. devices

Submission Details

510(k) Number K201319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2020
Decision Date June 17, 2020
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 416
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K201319.
RetroFix
K200226 · Retrofix Screws, LLC · Jun 2020
DuoHex CH Cannulated Hammertoe System
K200840 · Nextremity Solutions, Inc. · Jun 2020
InFrame™ Cannulated Fixation System
K201430 · Exsomed Corp. · Jun 2020
InCore MPJ System
K200124 · Nextremity Solutions, Inc. · May 2020
Healix Compression Screw System
K200914 · Nvision Biomedical Technologies, Inc. · May 2020
Headless Compression Screw System
K200259 · Osteocentric Extremities, LLC · May 2020