Cleared Traditional

K180539 - Deformity Analysis and Correction Software (DACS) and Instrumentation (FDA 510(k) Clearance)

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

K180539 · Arrowhead Medical Device Technologies, LLC · Orthopedic device
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Aug 2018
Decision
166d
Days
Class 2
Risk

K180539 is an FDA 510(k) clearance for the Deformity Analysis and Correction Software (DACS) and Instrumentation. Classified as Software For Diagnosis/treatment (product code OSN), Class II - Special Controls.

Submitted by Arrowhead Medical Device Technologies, LLC (Collierville, US). The FDA issued a Cleared decision on August 13, 2018 after a review of 166 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 Arrowhead Medical Device Technologies, LLC devices

Submission Details

510(k) Number K180539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2018
Decision Date August 13, 2018
Days to Decision 166 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
44d slower than avg
Panel avg: 122d · This submission: 166d
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.