Cleared Traditional

K213905 - ONX Large External Fixation System

K213905 is an FDA 510(k) clearance for ONX Large External Fixation System, manufactured by Orthonovis, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K213905 · Orthonovis, Inc. · Orthopedic device
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Aug 2022
Decision
254d
Days
Class 2
Risk

K213905 is an FDA 510(k) clearance for the ONX Large External Fixation System. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Orthonovis, Inc. (Palm Coast, US). The FDA issued a Cleared decision on August 25, 2022 after a review of 254 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.

View all Orthonovis, Inc. devices

FDA 510(k) Submission Details - K213905

510(k) Number K213905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2021
Decision Date August 25, 2022
Days to Decision 254 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
132d slower than avg
Panel avg: 122d · This submission: 254d
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 298
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