Cleared Traditional

ELEOS™ with NanoCept® Technology Limb Salvage System (K253066) - FDA 510(k) Clearance

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

K253066 · Onkos Surgical, Inc. · Orthopedic device
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Jun 2026
Decision
259d
Days
Class 2
Risk

K253066 is an FDA 510(k) clearance for the ELEOS™ with NanoCept® Technology 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, Inc. (Parsippany, US). The FDA issued a Cleared decision on June 8, 2026 after a review of 259 days - an extended review cycle.

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 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 Onkos Surgical, Inc. devices

Submission Details

510(k) Number K253066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2025
Decision Date June 08, 2026
Days to Decision 259 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 122d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.