Cleared Traditional

K143146 - Nexis osteosynthesis snap-off screws

K143146 is an FDA 510(k) clearance for Nexis osteosynthesis snap-off screws, manufactured by Novastep. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K143146 · Novastep · Orthopedic device
Download Printable Device Report (PDF)
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Feb 2015
Decision
95d
Days
Class 2
Risk

K143146 is an FDA 510(k) clearance for the Nexis osteosynthesis snap-off screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Novastep (Saint Gregoire, FR). The FDA issued a Cleared decision on February 6, 2015 after a review of 95 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 Novastep devices

FDA 510(k) Submission Details - K143146

510(k) Number K143146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2014
Decision Date February 06, 2015
Days to Decision 95 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
27d faster than avg
Panel avg: 122d · This submission: 95d
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 681
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K143146.
aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium
K150974 · Aap Implantate AG · Apr 2015
Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw
K143165 · Zimmer, Inc. · Mar 2015
Extremity Medical Calcaneal Osteotomy Device
K150309 · Extremity Medical, LLC · Mar 2015
Extremity Medical Calcaneal Osteotomy Device
K143402 · Extremity Medical, LLC · Feb 2015
Cannulated Screw System
K143460 · Wrightmedicaltechnologyinc · Jan 2015
Arthrex Low Profile Screws
K143614 · Arthrex, Inc. · Jan 2015