Chrysalis Intelligence · Product Codes · QZZ

QZZ · Limb And Joint Salvage Device With Coating For Bacteria Reduction

Orthopedic · 3 clearances · 1 unique sponsors

Device class
Class II
Regulation 888.3900
Total clearances
3
2024-04-05 → 2026-06-08
Last 12 months
2
Unique sponsors
1
Definition

What is 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.
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3900
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Onkos Surgical 3 2 2026-06-08
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
20955 CPT High CPT for resection/replacement of femur or knee joint with prosthesis, common limb salvage indication
20956 CPT High Standard CPT for resection/replacement of tibia or fibula with prosthesis, typical limb salvage procedure
20957 CPT Medium CPT for resection/replacement of humerus or shoulder joint, alternative limb salvage site
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-08 K253066 Onkos Surgical, Inc. ELEOS™ with NanoCept® Technology Limb Salvage System
2025-10-15 K252920 Onkos Surgical, Inc. ELEOS™ Limb Salvage System with NanoCept® Technology
2024-04-05 DEN210058 Onkos Surgical ELEOSx™ Limb Salvage System