Cleared Traditional

K182919 - SI-Restore Sacroiliac Joint Fixation Sy...

K182919 is the FDA 510(k) clearance for SI-Restore Sacroiliac Joint Fixation Sy... by Biofusion Medical. It is a Class 2 Orthopedic device (product code OUR) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K182919 · Biofusion Medical · Orthopedic device
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Jan 2019
Decision
98d
Days
Class 2
Risk

K182919 is an FDA 510(k) clearance for the SI-Restore® Sacroiliac Joint Fixation System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Biofusion Medical (Austin, US). The FDA issued a Cleared decision on January 25, 2019 after a review of 98 days - within the typical 510(k) review window.

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 Biofusion Medical devices

Submission Details

510(k) Number K182919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2018
Decision Date January 25, 2019
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
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 Consultant

Surgop Support
Daniel Lanois

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 105
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K182919.
SambaScrew 3D SI Fusion System
K183342 · Orthofix, Inc. · Apr 2019
iFuse Implant System®
K190230 · SI-BONE, Inc. · Apr 2019
SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments
K183119 · Globus Medical, Inc. · Feb 2019
iFuse Implant System®
K182983 · SI-BONE, Inc. · Nov 2018
Outlet Sacroiliac Joint Fusion System
K181881 · Sij Surgical · Oct 2018
PathLoc-SI Joint Fusion System
K181600 · L & K Biomed Co., Ltd. · Jul 2018