| Device |
limb and joint salvage device with coating for bacteria reduction |
| Definition |
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. |
| Physical State |
Metallic devices with or without polymer joint replacement bearings that replace structures of the skeleton and extremities. Implants contain modular or non-modular designs which can include stems, bone replacement segments, and joint replacement components that constrain motion in one or more planes. The coating is covalently bonded to the surface. |
| Technical Method |
Resection and replacement of an extremity bone or an extremity bone and the surrounding joint(s) in a skeletally mature patient. The coating kills bacteria through mechanical mechanisms. |
| Target Area |
Extremity bones and surrounding joints |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | QZZ |
|---|
| Premarket Review |
Joint Arthroplasty Devices
(DHT6A)
Joint Arthroplasty Devices
(DHT6A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3900
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
