| Device |
prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive |
| Regulation Description |
Hip joint metal/polymer constrained cemented or uncemented prosthesis. |
| Definition |
For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered. |
| Physical State |
System contains acvetabular screws, acetabular shell, constrained UHMWPE acetabular liner doped with an additive, a femoral ball, and a metallic femoral stem. |
| Technical Method |
This device is intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. The liner constrains the head such that it prevent axial dislocation. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene containing an additive such as a-tocopherol articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The shell and stem can be attached to the bone by either cemented, pressfit, or biological fixation. |
| Target Area |
Hip |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | PBI |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Joint Arthroplasty Devices
(DHT6A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3310
|
|---|
| 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
|
| Guidance Document
|
| Third Party Review |
Not Third Party Eligible |
