Cleared Special

K261809 - Interwedge Standalone Lateral

K261809 is the FDA 510(k) clearance for Interwedge Standalone Lateral by Foundation Surgical Group. It is a Class 2 Orthopedic device (product code OVD) cleared through the Special 510(k) pathway after a 60-day FDA review.

K261809 · Foundation Surgical Group · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
60d
Days
Class 2
Risk

K261809 is an FDA 510(k) clearance for the Interwedge® Standalone Lateral. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Foundation Surgical Group (Scottsdale, US). The FDA issued a Cleared decision on July 31, 2026 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Foundation Surgical Group devices

Submission Details

510(k) Number K261809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2026
Decision Date July 31, 2026
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 145
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K261809.
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