DeviceClearance

Product code OJP— Neurology

CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM

Classification name
Orthopedic Computer Controlled Surgical System
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Total cleared
4
First cleared
Most recent

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).”

— U.S. Food and Drug Administration, device classification record for product code OJP under 21 CFR 882.4560, via openFDA

Market context for product code OJP

FDA has cleared 4 devices under product code OJP between 2008 and 2015, filed by 3 applicant companies. 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.

Clearances per year

Top applicants under product code OJP

Recent clearances under product code OJP

Data sourced from openFDA. This site is unofficial and independent of the FDA.