Cleared Traditional

K203228 - DART-FIRE EDGE Cannulated Screw System

K203228 is an FDA 510(k) clearance for DART-FIRE EDGE Cannulated Screw System, manufactured by Wright Medical. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K203228 · Wright Medical · Orthopedic device
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May 2021
Decision
190d
Days
Class 2
Risk

K203228 is an FDA 510(k) clearance for the DART-FIRE EDGE Cannulated Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Wright Medical (Memphis, US). The FDA issued a Cleared decision on May 11, 2021 after a review of 190 days - an extended review 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: 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 Wright Medical devices

FDA 510(k) Submission Details - K203228

510(k) Number K203228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2020
Decision Date May 11, 2021
Days to Decision 190 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
68d slower than avg
Panel avg: 122d · This submission: 190d
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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K203228.
Medline UNITE® Digital Fusion Screw System
K211944 · Medline Industries, Inc. · Jul 2021
Arthrex Beveled FT Screws
K210994 · Arthrex, Inc. · Jun 2021
Axis Charcot Fixation System
K211261 · Extremity Medical, LLC · May 2021
Cannulated Fasteners and Nuts
K210754 · OsteoCentric Technologies · Apr 2021
LTJ Screws and Washer
K210268 · Azurmeds, Inc. · Feb 2021
Dynanail Mini Hybrid
K203381 · MedShape, Inc. · Jan 2021