Cleared Special

K233223 - OGmend® Implant Enhancement System (FDA 510(k) Clearance)

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

K233223 · Woven Orthopedic Technologies · Orthopedic device
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Oct 2023
Decision
28d
Days
Class 2
Risk

K233223 is an FDA 510(k) clearance for the OGmend® Implant Enhancement System. Classified as Screw Sleeve Bone Fixation Device, Spine (product code QVI), Class II - Special Controls.

Submitted by Woven Orthopedic Technologies (Manchester, US). The FDA issued a Cleared decision on October 26, 2023 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3043 - 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 Woven Orthopedic Technologies devices

Submission Details

510(k) Number K233223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2023
Decision Date October 26, 2023
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QVI Screw Sleeve Bone Fixation Device, Spine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3043
Definition A Spinal Screw Sleeve Bone Fixation Device Is Intended To Be Implanted In Conjunction With A Non-resorbable, Metallic Bone Screw Where The Screw Has Lost Purchase Due To Loosening, Backout, Or Breakage. The Device Fits Between The Screw Threads And Surrounding Bone, And Provides Increased Surface Area To Create An Interference Fit To Restore Stability Of The Implant Construct.
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.