Product code QZZ— Orthopedic

“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.”

FDA has cleared 3 devices under product code QZZ between 2024 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20261 clearance
• 20251 clearance
• 20241 clearance

• Onkos Surgical, Inc.2 clearances
• Onkos Surgical1 clearance

• K253066 — ELEOS with NanoCept® Technology Limb Salvage SystemOnkos Surgical, Inc.·2026-06-08
• K252920 — ELEOS Limb Salvage System with NanoCept® TechnologyOnkos Surgical, Inc.·2025-10-15
• DEN210058 — ELEOSx Limb Salvage SystemOnkos Surgical·2024-04-05