Product code PLW— Orthopedic
Acetabular Cup Orientation System
- Device class
- Class 2
- Regulation
- 21 CFR 888.3350
- Advisory panel
- Orthopedic
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code PLW
FDA has cleared device under product code PLW, all in 2015, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code PLW
Recent clearances under product code PLW
Data sourced from openFDA. This site is unofficial and independent of the FDA.