| Device |
shoulder spacer for massive irreparable rotator cuff tear, resorbable, inflatable, non-fixed |
| Regulation Description |
Resorbable shoulder spacer. |
| Definition |
A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears. |
| Physical State |
Non-rigid device intended to be resorbed over time. |
| Technical Method |
The implant is designed to act as a spacer, creating a physical barrier between tissues in the subacromial space. Once positioned in the tissue space, the implant is filled with sterile solution to the pre-defined volume, sealed, and released. Following implantation, it is designed to biodegrade over a certain period of time. |
| Target Area |
Shoulder (subacromial space) |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | QPQ |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Joint Arthroplasty Devices
(DHT6A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3630
|
|---|
| 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 |
