Cleared Traditional

K173752 - SI Screw System

K173752 is an FDA 510(k) clearance for SI Screw System, manufactured by Zavation Medical Products, LLC. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K173752 · Zavation Medical Products, LLC · Orthopedic device
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Mar 2018
Decision
98d
Days
Class 2
Risk

K173752 is an FDA 510(k) clearance for the SI Screw System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Zavation Medical Products, LLC (Flowood, US). The FDA issued a Cleared decision on March 16, 2018 after a review of 98 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 Zavation Medical Products, LLC devices

FDA 510(k) Submission Details - K173752

510(k) Number K173752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2017
Decision Date March 16, 2018
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
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 K173752.
Life Spine SIMPACT Sacroiliac Joint Fixation System
K180749 · Life Spine, Inc. · Jun 2018
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
K180818 · Tenon Medical, Inc. · Jun 2018
UNITY Sacroiliac Joint Fixation System
K173201 · Huvexel Co. , Ltd. · Apr 2018
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
K171595 · Medacta International S.A. · Aug 2017
SICAGE™ System
K170475 · Sicage, LLC · May 2017
iFuse Implant System® - iFuse-3D implant
K162733 · SI-BONE, Inc. · Mar 2017