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 (all years, FDA)

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

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).