Cleared Special

K252920 - ELEOS™ Limb Salvage System with NanoCept® Technology (FDA 510(k) Clearance)

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

K252920 · Onkos Surgical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
33d
Days
Class 2
Risk

K252920 is an FDA 510(k) clearance for the ELEOS™ Limb Salvage System with NanoCept® Technology. Classified as Limb And Joint Salvage Device With Coating For Bacteria Reduction (product code QZZ), Class II - Special Controls.

Submitted by Onkos Surgical, Inc. (Parsippany, US). The FDA issued a Cleared decision on October 15, 2025 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3900 - 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 Onkos Surgical, Inc. devices

Submission Details

510(k) Number K252920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2025
Decision Date October 15, 2025
Days to Decision 33 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
89d faster than avg
Panel avg: 122d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

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.