Cleared Traditional

K183342 - SambaScrew 3D SI Fusion System

K183342 is an FDA 510(k) clearance for SambaScrew 3D SI Fusion System, manufactured by Orthofix, Inc.. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K183342 · Orthofix, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K183342

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
Combination Product No
PCCP Authorized No
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.

OUR Device Classification - Class 2, Special Controls

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.

Regulatory Peers - OUR Sacroiliac Joint Fixation

All 130
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K183342.
M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System
K193083 · Medacta International S.A. · Dec 2019
Genesys Spine Sacroiliac Joint Fusion System
K191748 · Genesys Spine · Sep 2019
EVOL® -SI Joint Fusion System
K190025 · Cutting Edge Spine, LLC · Aug 2019
iFuse Implant System®
K190230 · SI-BONE, Inc. · Apr 2019
SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments
K183119 · Globus Medical, Inc. · Feb 2019
SI-Restore® Sacroiliac Joint Fixation System
K182919 · Biofusion Medical · Jan 2019