PLF · Class II · 21 CFR 888.3030

FDA Product Code PLF: Bone Wedge

FDA product code PLF covers bone wedges used as grafts or spacers in orthopedic procedures.

These shaped bone or synthetic spacers are used with ancillary fixation to correct angular deformities, restore joint alignment, and fill bone defects created during corrective osteotomies and revision surgery. They are commonly used in high tibial osteotomy and distal femoral osteotomy.

PLF devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Nvision Biomedical Technologies, Inc., Nvision Biomedical Technologies and MiRus, LLC.

18
Total
18
Cleared
121d
Avg days
2015
Since
Growing category - 5 submissions in the last 2 years vs 3 in the prior period
Review times increasing: avg 139d recently vs 114d historically

FDA 510(k) Cleared Bone Wedge Devices (Product Code PLF)

18 devices
1–18 of 18
Cleared Feb 19, 2026
ATLAS™ Expandable Osteotomy Wedge System
K252733
MiRus, LLC
Orthopedic · 175d
Cleared Oct 17, 2025
Osteotomy Wedge System
K252254
Sinaptic Surgical
Orthopedic · 88d
Cleared Sep 25, 2025
Auxano® Wedge Fixation System
K251791
Auxano Medical, LLC
Orthopedic · 106d
Cleared Dec 06, 2024
OsteoSinter® EVANS and COTTON wedges and related accessories
K240461
Ames Medical Prosthetic Solutions, S.A.U.
Orthopedic · 294d
Cleared Nov 08, 2024
Trigon PEEK HA Wedges
K243231
Nvision Biomedical Technologies
Orthopedic · 30d
Cleared Jan 26, 2024
Trigon Trigon HA Stand-Alone Wedge Fixation System
K234116
Nvision Biomedical Technologies
Orthopedic · 30d
Cleared Aug 22, 2023
TITAN 3-D Wedge System
K231496
Paragon 28, Inc.
Orthopedic · 90d
Cleared Dec 01, 2022
Trigon™ HA Stand-Alone Wedge Fixation System
K223226
Nvision Biomedical Technologies, Inc.
Orthopedic · 44d
Cleared Feb 23, 2022
Trigon HA Wedge Fixation System
K220197
Nvision Biomedical Technologies, Inc.
Orthopedic · 30d
Cleared Jun 17, 2021
Restor3d Utility Wedge
K201314
Restor3D, Inc.
Orthopedic · 395d
Cleared Dec 21, 2020
Trigon HA Stand-Alone Wedge Fixation System
K203445
Nvision Biomedical Technologies, Inc.
Orthopedic · 28d
Cleared Feb 25, 2020
Trigon HA Stand-Alone Wedge Fixation System
K193414
Nvision Biomedical Technologies, Inc.
Orthopedic · 78d
Cleared Dec 23, 2019
Trigon™ Ti Stand-Alone Wedge Fixation System
K192645
Nvision Biomedical Technologies, Inc.
Orthopedic · 90d
Cleared Nov 05, 2019
ADI TiDAL Osteotomy Wedge
K191047
Additive Device, Inc. (Adi) D/B/A Restor3D
Orthopedic · 200d

About Product Code PLF - Regulatory Context

510(k) Submission Activity

18 total 510(k) submissions under product code PLF since 2015, with 18 receiving FDA clearance (average review time: 121 days).

Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - PLF Product Code

Recent submissions under PLF have taken an average of 139 days to reach a decision - up from 114 days historically. Manufacturers should account for longer review timelines in current project planning.

PLF devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →