FDA Product Code QZZ: Limb And Joint Salvage Device With Coating For Bacteria Reduction
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.
Leading manufacturers include Onkos Surgical and Onkos Surgical, Inc..
FDA 510(k) Cleared Limb And Joint Salvage Device With Coating For Bacteria Reduction Devices (Product Code QZZ)
About Product Code QZZ - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QZZ since 2024, with 1 receiving FDA clearance (average review time: 430 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QZZ have taken an average of 33 days to reach a decision - down from 827 days historically, suggesting improved FDA processing for this classification.
QZZ devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →