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 (last 3 years): 1

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).

Official FDA classification page: PLW

Classification and pathway per current FDA publications. Data from openFDA (CC0).