Cleared Traditional

K140550 - ORTHOHUB EXTERNAL FIXATOR SOFTWARE (FDA 510(k) Clearance)

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

K140550 · Orthohub, Inc. · Orthopedic device
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Aug 2014
Decision
174d
Days
Class 2
Risk

K140550 is an FDA 510(k) clearance for the ORTHOHUB EXTERNAL FIXATOR SOFTWARE. Classified as Software For Diagnosis/treatment (product code OSN), Class II - Special Controls.

Submitted by Orthohub, Inc. (Menlo Park, US). The FDA issued a Cleared decision on August 25, 2014 after a review of 174 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 Orthohub, Inc. devices

Submission Details

510(k) Number K140550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2014
Decision Date August 25, 2014
Days to Decision 174 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 122d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OSN Software For Diagnosis/treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
Definition Software Associated With An Orthopedic Trauma Device Which Is Intended For The Diagnosis Or Treatment Of Traumatic Or Reconstructive Orthopedic Conditions
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.