| Device |
acetabular cup orientation system |
| Regulation Description |
Hip joint metal/polymer semi-constrained cemented prosthesis. |
| Definition |
The acetabular cup orientation system is intended to be used as a surgical instrument to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty. The device utilizes anatomic landmarks of the pelvis that are clearly identifiable on pre-operative imaging scans. |
| Physical State |
A patient-matched acetabular guide, made of polymeric material and with a patient-matched surface that is congruent to the mating acetabular surface. May be manufactured through an additive manufacturing process. |
| Technical Method |
The device consists of a software component that generates a pre-operative plan based on the medical imaging data and a hardware component, the patient-matched guide that is positioned onto/within the acetabulum by mating the patient-specific contact surface to its corresponding anatomical surface. The guide is used to place an alignment pin at/near the acetabular rim in a pre-operatively desired orientation. The alignment pin is used as a visual reference to assist in the intra-operative orientation of the acetabular component during THA, so the surgeon may visually ensure that the orientation of the alignment pin matches the normal direction of the acetabular component. |
| Target Area |
Acetabulum |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | PLW |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Joint Arthroplasty Devices
(DHT6A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3350
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standards
|
| Guidance Document
|
| Third Party Review |
Not Third Party Eligible |
