Cleared Traditional

K143460 - Cannulated Screw System

K143460 is an FDA 510(k) clearance for Cannulated Screw System, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K143460 · Wrightmedicaltechnologyinc · Orthopedic device
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Jan 2015
Decision
50d
Days
Class 2
Risk

K143460 is an FDA 510(k) clearance for the Cannulated Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on January 23, 2015 after a review of 50 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K143460

510(k) Number K143460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2014
Decision Date January 23, 2015
Days to Decision 50 days
Submission Type Traditional
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
72d faster than avg
Panel avg: 122d · This submission: 50d
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 951
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K143460.
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CrossRoads Screw System
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Arthrex Low Profile Screws
K143614 · Arthrex, Inc. · Jan 2015
INFIX CANNULATED SCREW SYSTEM
K142057 · Infix Medical, LLC · Jan 2015