Cleared Traditional

K230927 - OptiMesh Multiplanar Expandable Interbody Fusion System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230927 · Spineology, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
212d
Days
Class 2
Risk

K230927 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 November 1, 2023 after a review of 212 days - an extended review cycle.

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

Submission Details

510(k) Number K230927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2023
Decision Date November 01, 2023
Days to Decision 212 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
90d slower than avg
Panel avg: 122d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.