FDA product code PLW: Acetabular Cup Orientation System
PLW is the FDA product code for acetabular cup orientation system. It is a Class II device, regulated under 21 CFR 888.3350 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under PLW. The average 510(k) review took 216 days (median 216).
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.
Classification
| Field | Value |
|---|---|
| Device name | Acetabular Cup Orientation System |
| Device class | Class II |
| Regulation | 21 CFR 888.3350 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every PLW clearance
Top PLW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Materialise NV | 1 | 2015-10-27 |
Most recent PLW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150780 | Materialise NV | Acetabular Cup Orientation System | 2015-10-27 | 216 |
Recalls for PLW devices
openFDA lists no recalls for product code PLW.
Frequently asked questions
What is FDA product code PLW?
PLW is the FDA product code for acetabular cup orientation system. It is a Class II device, regulated under 21 CFR 888.3350 and reviewed by the Orthopedic panel.
What device class is PLW?
Class II, regulation 21 CFR 888.3350. Typical premarket route: 510(k).
How long does a 510(k) take for product code PLW?
Across 1 cleared submissions the average was 216 days from receipt to decision (median 216).
Which companies have the most PLW clearances?
Materialise NV (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PLW
- Run a recall and safety report across every PLW manufacturer
- Watch product code PLW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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