Cleared Traditional

K111801 - SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM

K111801 is an FDA 510(k) clearance for SIMMETRY(TM) 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 24-day FDA review.

K111801 · Zyga Technology, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
24d
Days
Class 2
Risk

K111801 is an FDA 510(k) clearance for the SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Zyga Technology, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 21, 2011 after a review of 24 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zyga Technology, Inc. devices

FDA 510(k) Submission Details - K111801

510(k) Number K111801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2011
Decision Date July 21, 2011
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
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 K111801.
SILEX SACROILIAC JOINT FUSION SYSTEM
K123702 · X-Spine Systems, Inc. · Mar 2013
IFUSE IMPLANT SYSTEM
K122074 · SI-BONE, Inc. · Oct 2012
SI-FIX SACROILIAC JOINT FUSION SYSTEM
K110472 · Medtronic Sofamor Danek · May 2012
IFUSE IMPLANT SYSTEM
K110838 · SI-BONE, Inc. · Apr 2011
MODIFICATION TO SI JOINT FUSION SYSTEM
K092375 · SI-BONE, Inc. · Sep 2009
SI JOINT FUSION SYSTEM
K080398 · SI-BONE, Inc. · Nov 2008