Cleared Special

Integrity-SI Fusion System (K222512) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K222512 · OsteoCentric Technologies · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
24d
Days
Class 2
Risk

K222512 is an FDA 510(k) clearance for the Integrity-SI Fusion System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by OsteoCentric Technologies (Logan, US). The FDA issued a Cleared decision on September 12, 2022 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all OsteoCentric Technologies devices

Submission Details

510(k) Number K222512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2022
Decision Date September 12, 2022
Days to Decision 24 days
Submission Type Special
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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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

Telos Partners, LLC
Ken Riordan

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 99
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K222512.
UNITY Sacroiliac Joint Fixation System
K222448 · Dio Medical Corporation · Oct 2022
SILO TFX MIS Sacroiliac Joint Fixation System
K221047 · Aurora Spine, Inc. · Oct 2022
iFuse TORQ® Implant System
K222605 · SI-BONE, Inc. · Sep 2022
Camber Sacroiliac (SI) Fixation System
K203503 · Camber Spine Technologies, LLC · Sep 2022
TransLoc 3D
K211496 · Foundation Fusion Solutions, LLC (Dba Cornerloc) · Jul 2022
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System
K221050 · Aegis Spine, Inc. · Jun 2022