Cleared Traditional

Siconus SI Joint Fixation System (K162121) - FDA 510(k) Clearance

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

K162121 · Camber Spine Technologies · Orthopedic device
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Jan 2017
Decision
170d
Days
Class 2
Risk

K162121 is an FDA 510(k) clearance for the Siconus SI Joint Fixation System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Camber Spine Technologies (Wayne, US). The FDA issued a Cleared decision on January 18, 2017 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 Camber Spine Technologies devices

Submission Details

510(k) Number K162121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2016
Decision Date January 18, 2017
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.

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.

Regulatory Peers - OUR Sacroiliac Joint Fixation

All 100
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K162121.
UNITY Sacroiliac Joint Fixation System
K173201 · Huvexel Co. , Ltd. · Apr 2018
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
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
SI-FIX SACROILIAC JOINT FUSION SYSTEM
K110472 · Medtronic Sofamor Danek · May 2012