Device class
Class II
Regulation 888.3900
Total clearances
3
2024-04-05 → 2026-06-08
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.
Classification details
Medical specialty
Orthopedic
Regulation number
888.3900
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.
| Code | Type | Description | Confidence | Rationale |
| 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