Cleared Traditional

K161755 - Integrity-SI TM Fusion System

K161755 is an FDA 510(k) clearance for Integrity-SI TM Fusion System, manufactured by Coorstek Medical. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K161755 · Coorstek Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
170d
Days
Class 2
Risk

K161755 is an FDA 510(k) clearance for the Integrity-SI TM Fusion System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Coorstek Medical (Providence, US). The FDA issued a Cleared decision on December 14, 2016 after a review of 170 days - an extended review cycle.

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 Coorstek Medical devices

FDA 510(k) Submission Details - K161755

510(k) Number K161755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2016
Decision Date December 14, 2016
Days to Decision 170 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
48d slower than avg
Panel avg: 122d · This submission: 170d
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 120
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K161755.
SI Screw System
K173752 · Zavation Medical Products, LLC · Mar 2018
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
K171595 · Medacta International S.A. · Aug 2017
iFuse Implant System® - iFuse-3D implant
K162733 · SI-BONE, Inc. · Mar 2017
PathLoc-SI Joint Fusion System
K153656 · L & K Biomed Co., Ltd. · Nov 2016
RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems
K161210 · Medtronic Sofamor Danek · Aug 2016
iFUSE Implant System
K160652 · SI-BONE, Inc. · Jun 2016