Cleared Traditional

K183342 - SambaScrew 3D SI Fusion System (FDA 510(k) Clearance)

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

K183342 · Orthofix, Inc. · Orthopedic device

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Apr 2019

Decision

148d

Days

Class 2

Risk

K183342 is an FDA 510(k) clearance for the SambaScrew 3D SI Fusion System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Orthofix, Inc. (Lewisville, US). The FDA issued a Cleared decision on April 30, 2019 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Orthofix, Inc. devices

Submission Details

510(k) Number	K183342 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 03, 2018
Decision Date	April 30, 2019
Days to Decision	148 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

26d slower than avg

Panel avg: 122d · This submission: 148d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	OUR Sacroiliac Joint Fixation
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 888.3040
Definition	Sacroiliac Joint Fusion

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.