Cleared Traditional

K202833 - Sequel External Fixation Device

K202833 is an FDA 510(k) clearance for Sequel External Fixation Device, manufactured by Sequel Medical, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K202833 · Sequel Medical, Inc. · Orthopedic device
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Jan 2021
Decision
116d
Days
Class 2
Risk

K202833 is an FDA 510(k) clearance for the Sequel External Fixation Device. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Sequel Medical, Inc. (Miami, US). The FDA issued a Cleared decision on January 19, 2021 after a review of 116 days - within the typical 510(k) review window.

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.

View all Sequel Medical, Inc. devices

FDA 510(k) Submission Details - K202833

510(k) Number K202833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2020
Decision Date January 19, 2021
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

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 304
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K202833.
MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
K211313 · Synthes USA Products, LLC · May 2021
OIC External Fixation System
K211112 · Orthopaedic Implant Company · May 2021
Hoffmann LRF System
K203568 · Stryker GmbH · Feb 2021
AutoStrut G2
K202810 · Orthospin, Ltd. · Jan 2021
Bfix Orthopedic External Fixator Systems
K200491 · Aike (Shanghai) Medical Instrument Co., Ltd. · Jan 2021
Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation
K201253 · Smith & Nephew · Dec 2020