Cleared Traditional

K151462 - SI-TECHNOLOGY SI-DESIS SCREWS

K151462 is an FDA 510(k) clearance for SI-TECHNOLOGY SI-DESIS SCREWS, manufactured by Si-Technology, LLC. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K151462 · Si-Technology, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
72d
Days
Class 2
Risk

K151462 is an FDA 510(k) clearance for the SI-TECHNOLOGY® SI-DESIS® SCREWS. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Si-Technology, LLC (Fort Collins, US). The FDA issued a Cleared decision on August 12, 2015 after a review of 72 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 Si-Technology, LLC devices

FDA 510(k) Submission Details - K151462

510(k) Number K151462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2015
Decision Date August 12, 2015
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
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 K151462.
iFuse Implant System(R)
K152681 · SI-BONE, Inc. · Mar 2016
The Entasis Dual-Lead Sacroiliac Implant
K152237 · Corelink, LLC · Feb 2016
iFuse Implant System
K151718 · SI-BONE, Inc. · Oct 2015
iFuse Implant System
K150875 · SI-BONE, Inc. · Jul 2015
SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
K150017 · Spinefrontier, Inc. · Apr 2015
SI-BONE iFuse Implant System
K150714 · SI-BONE, Inc. · Apr 2015