Cleared Special

K150073 - MICRONAIL Distal Radius System

K150073 is an FDA 510(k) clearance for MICRONAIL Distal Radius System, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 27-day FDA review.

K150073 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
27d
Days
Class 2
Risk

K150073 is an FDA 510(k) clearance for the MICRONAIL Distal Radius System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on February 10, 2015 after a review of 27 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K150073

510(k) Number K150073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2015
Decision Date February 10, 2015
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.

HSB Device Classification - Class 2, Special Controls

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 461
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K150073.
CalcaNail Orthopedic Nail
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PRECICE Intramedullary Limb Lengthening System
K150656 · Ellipse Technologies, Incorporated · Apr 2015
OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System
K142451 · Merete Medical GmbH · Feb 2015
Acumed Small Bone IM Nail System
K143276 · Acumed, LLC · Feb 2015
Sonoma Fibula Repair System
K142945 · Sonoma Orthopedic Products, Inc. · Jan 2015