| Device |
shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis |
| Definition |
A shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis is a device using a replacement humeral head made of ceramic materials, such as pyrolytic carbon,and a stem made of alloys, such as cobalt-chromium-molybdenum. It is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed with or without bone cement (§ 888.3027). This device is not intended for use in total shoulder arthroplasty. |
| Physical State |
Device made of more than one sub-component, that is, a modular ceramic humeral head which replaces the humeral articular surface, and an intramedullary stem made of metallic alloys, such as titanium or cobalt-chromium-molybdenum to be fixed without bone cement (888.3027). |
| Technical Method |
Replaces the articular surface and proximal end of the humerus. |
| Target Area |
Shoulder joint, proximal humerus. |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | QKW |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Joint Arthroplasty Devices
(DHT6A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3695
|
|---|
| 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 |
