K150780 is an FDA 510(k) clearance for the Acetabular Cup Orientation System. This device is classified as a Acetabular Cup Orientation System (Class II - Special Controls, product code PLW).
Submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on October 27, 2015, 216 days after receiving the submission on March 25, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3350. 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) Number | K150780 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2015 |
| Decision Date | October 27, 2015 |
| Days to Decision | 216 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PLW — Acetabular Cup Orientation System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3350 |
| 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. |