PLFClass II

Bone Wedge

21 CFR 888.3030 / Orthopedic

PLF is the FDA product code for Bone Wedge, a class II device type, regulated under 21 CFR 888.3030. FDA's definition for this code reads: "Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia". As of 2026-09-10, FDA records hold 18 510(k) clearances under this code, the most recent dated 2026-02-19, and 9 recalls.

Classification record

Product code: PLF
Device name: Bone Wedge
FDA definition: Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
Regulation: 21 CFR 888.3030
Device class: Class II
Review panel: Orthopedic
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 18
Ingested recalls: 9

Clearances, product code PLF

By decision year

18 clearances under product code PLF with a decision year between 2015 and 2026, 2024 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code PLF by decision year
Year	Clearances
2015	2
2017	2
2019	2
2020	2
2021	1
2022	2
2023	1
2024	3
2025	2
2026	1

Applicants with the most clearances

Product code PLF

Applicants holding the most 510(k) clearances under product code PLF
Applicant	Clearances
Nvision Biomedical Technologies, Inc	7
Paragon 28	2
Tyber Medical	2
Additive Device, Inc. (Adi) D/B/A Restor3D	1
Ames Medical Prosthetic Solutions, S.A.U.	1
Arthex, Inc.	1
Auxano Medical LLC	1
Mirus, LLC	1
restor3d, Inc.	1
Sinaptic Surgical	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 32 companies shown, in name order