Bone Wedge

FDA product code PLF · Class II (moderate risk) · 21 CFR 888.3030 · Orthopedic

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

18510(k) clearances
0PMA approvals
9recalls
Implantimplanted device

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K252733ATLAS™ Expandable Osteotomy Wedge SystemPLF · Traditional MiRus, LLC02/19/2026SE
K252254Osteotomy Wedge SystemPLF · Traditional Sinaptic Surgical10/17/2025SE
K251791Auxano® Wedge Fixation SystemPLF · Traditional Auxano Medical, LLC09/25/2025SE
K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesPLF · Abbreviated Ames Medical Prosthetic Solutions, S.A.U.12/06/2024SE
K243231Trigon PEEK HA WedgesPLF · Special Nvision Biomedical Technologies11/08/2024SE
K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemPLF · Special Nvision Biomedical Technologies01/26/2024SE
K231496TITAN 3-D Wedge SystemPLF · Traditional Paragon 28, Inc.08/22/2023SE
K223226Trigon™ HA Stand-Alone Wedge Fixation SystemPLF · Special Nvision Biomedical Technologies, Inc.12/01/2022SE
K220197Trigon HA Wedge Fixation SystemPLF · Special Nvision Biomedical Technologies, Inc.02/23/2022SE
K201314Restor3d Utility WedgePLF · Traditional Restor3D, Inc.06/17/2021SE
K203445Trigon HA Stand-Alone Wedge Fixation SystemPLF · Special Nvision Biomedical Technologies, Inc.12/21/2020SE
K193414Trigon HA Stand-Alone Wedge Fixation SystemPLF · Traditional Nvision Biomedical Technologies, Inc.02/25/2020SE
K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemPLF · Traditional Nvision Biomedical Technologies, Inc.12/23/2019SE
K191047ADI TiDAL Osteotomy WedgePLF · Traditional Additive Device, Inc. (Adi) D/B/A Restor3D11/05/2019SE
K171327Tyber Medical Wedge SystemPLF · Special Tyber Medical, LLC05/16/2017SE
K162241TITAN 3-D™ Wedge SystemPLF · Traditional Paragon 2804/03/2017SE
K151256Arthrex BioSync® Bone WedgePLF · Traditional Arthex, Inc.08/12/2015SE
K150394Tyber Medical Wedge SystemPLF · Traditional Tyber Medical, LLC07/28/2015SE

Recalls

RecallProductFirmInitiated
Z-2972-2026 Class IIICustom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number…Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels… Paragon 28, Inc.07/10/2026Open, Classified
Z-2971-2026 Class IIICustom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number…Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels… Paragon 28, Inc.07/10/2026Open, Classified
Z-0662-2020 Class IIP28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge…It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge… Paragon 28, Inc.09/28/2018Terminated
Z-1963-2016 Class IIBioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone…Potential for polystyrene particulate presence. Arthrex, Inc.04/22/2016Terminated
Z-1962-2016 Class IIBioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone…Potential for polystyrene particulate presence. Arthrex, Inc.04/22/2016Terminated
Z-1961-2016 Class IIBioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone…Potential for polystyrene particulate presence. Arthrex, Inc.04/22/2016Terminated
Z-1960-2016 Class IIBioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone…Potential for polystyrene particulate presence. Arthrex, Inc.04/22/2016Terminated
Z-1959-2016 Class IIBioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone…Potential for polystyrene particulate presence. Arthrex, Inc.04/22/2016Terminated
Z-1958-2016 Class IIBioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone…Potential for polystyrene particulate presence. Arthrex, Inc.04/22/2016Terminated