Not Cleared Direct

DEN180065 - OGmend Implant System (FDA 510(k) Clearance)

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

DEN180065 · Woven Orthopedic Technologies, LLC · Orthopedic device
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May 2020
Decision
505d
Days
Class 2
Risk

DEN180065 is an FDA 510(k) submission (not cleared) for the OGmend Implant System. Classified as Screw Sleeve Bone Fixation Device (product code QAC), Class II - Special Controls.

Submitted by Woven Orthopedic Technologies, LLC (Manchester, US). The FDA issued a Not Cleared (DENG) decision on May 1, 2020 after a review of 505 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 505 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Woven Orthopedic Technologies, LLC devices

Submission Details

510(k) Number DEN180065 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 13, 2018
Decision Date May 01, 2020
Days to Decision 505 days
Submission Type Direct
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
383d slower than avg
Panel avg: 122d · This submission: 505d
Pathway characteristics

Device Classification

Product Code QAC Screw Sleeve Bone Fixation Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3043
Definition A 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.