Cleared Traditional

K223075 - Ogmend® Implant Enhancement System (FDA 510(k) Clearance)

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

K223075 · Woven Orthopedic Technologies · Orthopedic device
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Feb 2023
Decision
150d
Days
Class 2
Risk

K223075 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 February 27, 2023 after a review of 150 days - an extended review cycle.

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

Submission Details

510(k) Number K223075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2022
Decision Date February 27, 2023
Days to Decision 150 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
28d slower than avg
Panel avg: 122d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.