Cleared Traditional

Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation (K201253) - FDA 510(k) Clearance

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

K201253 · Smith & Nephew · Orthopedic device
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Dec 2020
Decision
211d
Days
Class 2
Risk

K201253 is an FDA 510(k) clearance for the Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, IL.... Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Smith & Nephew (Cordova, US). The FDA issued a Cleared decision on December 8, 2020 after a review of 211 days - an extended review 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: 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.

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Submission Details

510(k) Number K201253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2020
Decision Date December 08, 2020
Days to Decision 211 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
89d slower than avg
Panel avg: 122d · This submission: 211d
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 179
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K201253.
Sequel External Fixation Device
K202833 · Sequel Medical, Inc. · Jan 2021
AutoStrut G2
K202810 · Orthospin, Ltd. · Jan 2021
Bfix Orthopedic External Fixator Systems
K200491 · Aike (Shanghai) Medical Instrument Co., Ltd. · Jan 2021
Circular Fixation with Balanced Cable Transport
K202762 · Smith & Nephew, Inc. · Nov 2020
Pitkar DeftFix System
K200728 · S.H.Pitkar Orthotools Pvt. , Ltd. · Oct 2020
Accessories for the SixFix® Hexapod Fixator
K200123 · Arrowhead De, LLC · Sep 2020