DeviceClearance

Product code PBF— Orthopedic

Newclip Patient-matched instrumentation non sterile PSI

Classification name
Orthopaedic Surgical Planning And Instrument Guides
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Total cleared
27
First cleared
Most recent

FDA classification definition

“As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.”

— U.S. Food and Drug Administration, device classification record for product code PBF under 21 CFR 888.3030, via openFDA

Market context for product code PBF

FDA has cleared 27 devices under product code PBF between 2012 and 2026, filed by 15 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 PBF

Adverse events under product code PBF

product code PBF
Injury
180
Total
180

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code PBF

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