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510(k) DEN210058

ELEOSx™ Limb Salvage System by Onkos Surgical — Product Code QZZ

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
April 5, 2024
Date Received
December 30, 2021
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Limb And Joint Salvage Device With Coating For Bacteria Reduction
Device Class
Class II
Regulation Number
888.3900
Review Panel
OR
Submission Type

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.

Other clearances by Onkos Surgical

  • K252920 — ELEOS™ Limb Salvage System with NanoCept® Technology (October 15, 2025)
  • K223348 — My3D® Personalized Pelvic Reconstruction (January 30, 2023)
  • K212815 — My3D® Personalized Pelvic Reconstruction (July 6, 2022)
  • K211677 — ELEOS Limb Salvage System (July 28, 2021)
  • K203815 — ELEOS Limb Salvage System with BioGrip (June 9, 2021)
  • K203588 — ELEOS™ Limb Salvage System (February 5, 2021)
  • K203090 — ELEOS Limb Salvage System featuring BIOGRIP (December 11, 2020)
  • K180130 — ELEOS™ Bipolar Acetabular System (February 23, 2018)
  • K161520 — ELEOS Limb Salvage System (October 28, 2016)

Other clearances for product code QZZ

  • K252920 — ELEOS™ Limb Salvage System with NanoCept® Technology (October 15, 2025)