Cleared Special

K231781 - OptiMesh Multiplanar Expandable Interbody Fusion System (FDA 510(k) Clearance)

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

K231781 · Spineology, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 2023
Decision
124d
Days
Class 2
Risk

K231781 is an FDA 510(k) clearance for the OptiMesh Multiplanar Expandable Interbody Fusion System. Classified as Intervertebral Body Graft Containment Device (product code OQB), Class II - Special Controls.

Submitted by Spineology, Inc. (Saint Paul, US). The FDA issued a Cleared decision on October 18, 2023 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3085 - 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 Spineology, Inc. devices

Submission Details

510(k) Number K231781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2023
Decision Date October 18, 2023
Days to Decision 124 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
2d slower than avg
Panel avg: 122d · This submission: 124d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OQB Intervertebral Body Graft Containment Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3085
Definition An Intervertebral Body Graft Containment Device Is A Non-rigid, Implanted Spinal Device That Is Designed To Contain Bone Graft Within Its Internal Cavity. The Device Is Inserted Into The Intervertebral Body Space Of The Spine And Is Intended As An Adjunct To Intervertebral Body 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.