Cleared Traditional

K183026 - Wright Jones Fracture System

K183026 is an FDA 510(k) clearance for Wright Jones Fracture 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 132-day FDA review.

K183026 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
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Mar 2019
Decision
132d
Days
Class 2
Risk

K183026 is an FDA 510(k) clearance for the Wright Jones Fracture 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 March 13, 2019 after a review of 132 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K183026

510(k) Number K183026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2018
Decision Date March 13, 2019
Days to Decision 132 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
10d slower than avg
Panel avg: 122d · This submission: 132d
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 933
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K183026.
Monster® Screw System
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Arthrex TensionLoc System
K183628 · Arthrex, Inc. · Mar 2019
OsteoCentric Bone Plate and Screw System
K190430 · Osteocentric Trauma · Mar 2019
ActivOrtho Nitinol Compression Screw System
K181610 · Activortho, Inc. · Mar 2019
INnate Cannulated Screw System
K183603 · Exsomed Corporation · Mar 2019
CurvaFix Intramedullary Rodscrew System
K180050 · Curvafix, Inc. · Mar 2019