| Device |
prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented |
| Regulation Description |
Shoulder joint metal/polymer semi-constrained cemented prosthesis. |
| Definition |
Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures. |
| Physical State |
May include: Humeral stem Humeral neck Humeral tray Glenoid component Glenoid tray Glenosphere Fixation screws Instrumentation |
| Technical Method |
To be implanted to replace a shoulder joint. It limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device includes prosthesis that have a muheral component mode of alloys, such as CoCr or Ti alloys, and and a glenoid components made of ultra-high molecular weight polyethylene plus an additive, such as á-tocopherol. Reverse shoulder have a glenosphere made from CoCr and a humeral tray made from ultra-high molecular weight polyethylene plus an additive. The tray attaches to a metallic humeral stem. |
| Target Area |
Shoulder |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | PAO |
|---|
| Premarket Review |
Joint Arthroplasty Devices
(DHT6A)
Joint Arthroplasty Devices
(DHT6A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3660
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standards
|
| Third Party Review |
Not Third Party Eligible |
