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PLF — Bone Wedge Class II

FDA Device Classification

Classification Details

Product Code
PLF
Device Class
Class II
Regulation Number
888.3030
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252733mirusATLAS™ Expandable Osteotomy Wedge SystemFebruary 19, 2026
K252254sinaptic surgicalOsteotomy Wedge SystemOctober 17, 2025
K251791auxano medicalAuxano® Wedge Fixation SystemSeptember 25, 2025
K240461ames medical prosthetic solutions, s.a.uOsteoSinter® EVANS and COTTON wedges and related accessoriesDecember 6, 2024
K243231nvision biomedical technologiesTrigon PEEK HA WedgesNovember 8, 2024
K234116nvision biomedical technologiesTrigon Trigon HA Stand-Alone Wedge Fixation SystemJanuary 26, 2024
K231496paragon 28TITAN 3-D Wedge SystemAugust 22, 2023
K223226nvision biomedical technologiesTrigon™ HA Stand-Alone Wedge Fixation SystemDecember 1, 2022
K220197nvision biomedical technologiesTrigon HA Wedge Fixation SystemFebruary 23, 2022
K201314restor3dRestor3d Utility WedgeJune 17, 2021
K203445nvision biomedical technologiesTrigon HA Stand-Alone Wedge Fixation SystemDecember 21, 2020
K193414nvision biomedical technologiesTrigon HA Stand-Alone Wedge Fixation SystemFebruary 25, 2020
K192645nvision biomedical technologiesTrigon™ Ti Stand-Alone Wedge Fixation SystemDecember 23, 2019
K191047additive device, inc. (adi) d/b/a restor3dADI TiDAL Osteotomy WedgeNovember 5, 2019
K171327tyber medicalTyber Medical Wedge SystemMay 16, 2017
K162241paragon 28TITAN 3-D™ Wedge SystemApril 3, 2017
K151256arthexArthrex BioSync® Bone WedgeAugust 12, 2015
K150394tyber medicalTyber Medical Wedge SystemJuly 28, 2015