| Device |
screw sleeve bone fixation device, spine |
| Regulation Description |
Screw sleeve bone fixation device. |
| Definition |
A spinal screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an interference fit to restore stability of the implant construct. |
| Physical State |
The device is a woven or braided non-resorbable polymer such as polyethylene terephthalate (PET). |
| Technical Method |
The device provides augmentation by interdigitating and mechanically wedging between the spinal screw threads and bone. |
| Target Area |
For use with spinal screws. |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | QVI |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Spinal Devices
(DHT6B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3043
|
|---|
| 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 |
