Cleared Traditional

K141549 - SImmetry Sacroiliac Joint Fusion System

K141549 is an FDA 510(k) clearance for SImmetry Sacroiliac Joint Fusion System, manufactured by Zyga Technology, Inc.. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K141549 · Zyga Technology, Inc. · Orthopedic device
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Jan 2015
Decision
218d
Days
Class 2
Risk

K141549 is an FDA 510(k) clearance for the SImmetry Sacroiliac Joint Fusion System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Zyga Technology, Inc. (Minnetonka, US). The FDA issued a Cleared decision on January 15, 2015 after a review of 218 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 Zyga Technology, Inc. devices

FDA 510(k) Submission Details - K141549

510(k) Number K141549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2014
Decision Date January 15, 2015
Days to Decision 218 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
96d slower than avg
Panel avg: 122d · This submission: 218d
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 K141549.
SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
K150017 · Spinefrontier, Inc. · Apr 2015
SI-BONE iFuse Implant System
K150714 · SI-BONE, Inc. · Apr 2015
LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM
K141246 · Life Spine, Inc. · Feb 2015
IFUSE IMPLANT SYSTEM
K141049 · SI-BONE, Inc. · Jul 2014
SILEX SACROILIAC JOINT FUSION SYSTEM
K140079 · X-Spine Systems, Inc. · Mar 2014
IFUSE IMPLANT SYSTEM
K131405 · SI-BONE, Inc. · Oct 2013