PLW

Acetabular Cup Orientation System

Product code

PLW

Device name

Acetabular Cup Orientation System

Device class

Class 2

21 CFR

21 CFR 888.3350

Medical specialty

Orthopedic

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).