DeviceClearance

Product code PLF— Orthopedic

Trigon HA Stand-Alone Wedge Fixation System

Classification name
Bone Wedge
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Total cleared
18
First cleared
Most recent

FDA classification definition

“Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.”

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

Market context for product code PLF

FDA has cleared 18 devices under product code PLF between 2015 and 2026, filed by 12 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 PLF

Recent clearances under product code PLF

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