Acetabular Cup Orientation System
The Acetabular Cup Orientation System (product code PLW) is a Class 2 orthopedic device intended as a surgical instrument to assist in the intraoperative orientation of acetabular cup components used with total hip arthroplasty, regulated under 888.3350. It uses anatomic landmarks of the pelvis identifiable on preoperative imaging scans to guide cup positioning. The device requires 510(k) clearance and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- PLW
- Device Class
- FDA class 2
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K150780 | Acetabular Cup Orientation System | Oct 27, 2015 | Substantially Equivalent | Materialise NV |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.