Cleared Traditional

K160427 - dynaMX(TM) Nitinol Compression Screw

K160427 is an FDA 510(k) clearance for dynaMX(TM) Nitinol Compression Screw, manufactured by Mx Orthopedics, Corp.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K160427 · Mx Orthopedics, Corp. · Orthopedic device
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Jun 2016
Decision
108d
Days
Class 2
Risk

K160427 is an FDA 510(k) clearance for the dynaMX(TM) Nitinol Compression Screw. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Mx Orthopedics, Corp. (Lexington, US). The FDA issued a Cleared decision on June 3, 2016 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Mx Orthopedics, Corp. devices

FDA 510(k) Submission Details - K160427

510(k) Number K160427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2016
Decision Date June 03, 2016
Days to Decision 108 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 122d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

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 735
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K160427.
The Hammertoe Correction System
K153065 · Life Spine, Inc. · Aug 2016
Arthrosurface Bone Screws
K161539 · Arthrosurface, Inc. · Jun 2016
The Life Spine Subtalar Implant System
K160169 · Life Spine · Jun 2016
Large Screws Range
K160617 · Newclip Technics · Jun 2016
MC-Subtalar(TM) II
K160548 · Merete Medical GmbH · Apr 2016
Biomet Variable Pitch Compression Screw System
K160058 · Biomet, Inc. · Mar 2016