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
Combination Product No
PCCP Authorized No
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 Consultant

Secure BioMed Evaluations
LINDA BRADDON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OUR Sacroiliac Joint Fixation

All 131
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
SImmetry Sacroiliac Joint Fusion System
K151818 · Zyga Technology, Inc. · Aug 2015
iFuse Implant System
K150875 · SI-BONE, Inc. · Jul 2015
SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
K150017 · Spinefrontier, Inc. · Apr 2015