Cleared Special

Integrity-SI® Fusion System (K230226) - FDA 510(k) Clearance

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

K230226 · OsteoCentric Technologies · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
237d
Days
Class 2
Risk

K230226 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 21, 2023 after a review of 237 days - an extended review 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. Standard predicate reliance. 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 K230226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2023
Decision Date September 21, 2023
Days to Decision 237 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 122d · This submission: 237d
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 Peers - OUR Sacroiliac Joint Fixation

All 99
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K230226.
TransLoc 3D
K232878 · Foundation Fusion Solutions, LLC (Dba Cornerloc) · Oct 2023
Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System
K232605 · Lesspine Innovations · Sep 2023
TiLink-P SI Joint Fusion System
K230857 · SurGenTec, LLC · Sep 2023
CATAMARAN SI Joint Fusion System
K231944 · Tenon Medical, Inc. · Aug 2023
Xenix Medical Sacroiliac Fixation System
K231829 · Ht Medical D.B.A. Xenix Medical · Aug 2023
TiLink-L Joint Fusion System
K231831 · Surgentec · Aug 2023