Cleared Traditional

K191748 - Genesys Spine Sacroiliac Joint Fusion S...

K191748 is the FDA 510(k) clearance for Genesys Spine Sacroiliac Joint Fusion S... by Genesys Spine. It is a Class 2 Orthopedic device (product code OUR) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K191748 · Genesys Spine · Orthopedic device
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Sep 2019
Decision
87d
Days
Class 2
Risk

K191748 is an FDA 510(k) clearance for the Genesys Spine Sacroiliac Joint Fusion System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Genesys Spine (Austin, US). The FDA issued a Cleared decision on September 26, 2019 after a review of 87 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 Genesys Spine devices

Submission Details

510(k) Number K191748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2019
Decision Date September 26, 2019
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
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 105
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K191748.
FIREBIRD SI Fusion System
K200696 · Orthofix, Inc. · Apr 2020
SI-BONE iFuse Implant System®
K193524 · SI-BONE, Inc. · Mar 2020
M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System
K193083 · Medacta International S.A. · Dec 2019
EVOL® -SI Joint Fusion System
K190025 · Cutting Edge Spine, LLC · Aug 2019
SambaScrew 3D SI Fusion System
K183342 · Orthofix, Inc. · Apr 2019
iFuse Implant System®
K190230 · SI-BONE, Inc. · Apr 2019