Not Cleared Direct

DEN210058 - ELEOSx™ Limb Salvage System (FDA 510(k) Clearance)

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

DEN210058 · Onkos Surgical · Orthopedic device
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Apr 2024
Decision
827d
Days
Class 2
Risk

DEN210058 is an FDA 510(k) submission (not cleared) for the ELEOSx™ Limb Salvage System. Classified as Limb And Joint Salvage Device With Coating For Bacteria Reduction (product code QZZ), Class II - Special Controls.

Submitted by Onkos Surgical (Parsippany, US). The FDA issued a Not Cleared (DENG) decision on April 5, 2024 after a review of 827 days.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3900 - 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 827 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.

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Submission Details

510(k) Number DEN210058 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 30, 2021
Decision Date April 05, 2024
Days to Decision 827 days
Submission Type Direct
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
705d slower than avg
Panel avg: 122d · This submission: 827d
Pathway characteristics

Device Classification

Product Code QZZ Limb And Joint Salvage Device With Coating For Bacteria Reduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3900
Definition A Limb And Joint Salvage Device With Quaternary Ammonium Compound Coating Is A Metallic Implant With Or Without Polymer Bearing For Bone And Joint Replacement. Implants Are For Resection And Replacement Of An Extremity Bone (including The Entire Bone, Epiphyseal Bone, Metaphyseal Bone, Or Diaphyseal Bone), Or An Extremity Bone And The Surrounding Joint(s) In A Skeletally Mature Patient. The Device Includes A Quaternary Ammonium Compound Coating That Is Covalently Bonded To The Device. Where Applied, The Coating Is Intended To Reduce Microbial Contamination On The Surface Of The Device Prior To Implantation. The Device Does Not Contain Antimicrobial Agents That Act Within Or On The Body And This Device Type Does Not Include Combination Products.
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.