Cleared Traditional

SIDEKICK EZ FRAME External Fixation System (K143220) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K143220 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
59d
Days
Class 2
Risk

K143220 is an FDA 510(k) clearance for the SIDEKICK EZ FRAME External Fixation System. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on January 8, 2015 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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

Submission Details

510(k) Number K143220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2014
Decision Date January 08, 2015
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 174
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K143220.
SALVATION® External Fixation System
K152045 · Wrightmedicaltechnologyinc · Aug 2015
Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System
K150818 · Zimmer, Inc. · May 2015
SALVATION External Fixation System
K150004 · Wrightmedicaltechnologyinc · Mar 2015
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software
K142520 · Smith & Nephew, Inc. · Nov 2014
XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
K141697 · Zimmer, Inc. · Sep 2014
XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
K131413 · Zimmer, Inc. · Jan 2014