OJP

Orthopedic Computer Controlled Surgical System

Product code: OJP
Device name: Orthopedic Computer Controlled Surgical System
Device class: Class 2
21 CFR: 21 CFR 882.4560
Medical specialty: Neurology
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 4

FDA classification definition

Pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision. Alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).

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

Official FDA classification page: OJP

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