510(k) K150780
K150780 is an FDA 510(k) premarket notification submitted by Materialise NV for the device "Acetabular Cup Orientation System". The FDA issued a decision of Substantially Equivalent on October 27, 2015. The device falls under product code PLW (Acetabular Cup Orientation System), a Class II device regulated under 21 CFR 888.3350. Materialise NV has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 2015
- Date Received
- March 25, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acetabular Cup Orientation System
- Device Class
- Class II
- Regulation Number
- 888.3350
- Review Panel
- OR
- Submission Type
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.