Atlas FDA

PLF

18 FDA 510(k) clearances · Product code

90 daysmedian time to decision
294 days90th percentile
18clearances measured

FDA profile

Official device name
Bone Wedge
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Medical specialty
Orthopedic
Flags
Implant
FDA definition
Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
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RecordFirmDate
ATLAS™ Expandable Osteotomy Wedge System (K252733)MiRus, LLC2026-02-19
Osteotomy Wedge System (K252254)Sinaptic Surgical2025-10-17
Auxano® Wedge Fixation System (K251791)Auxano Medical, LLC2025-09-25
OsteoSinter® EVANS and COTTON wedges and related accessories (K240461)Ames Medical Prosthetic Solutions, S.A.U.2024-12-06
Trigon PEEK HA Wedges (K243231)Nvision Biomedical Technologies2024-11-08
Trigon Trigon HA Stand-Alone Wedge Fixation System (K234116)Nvision Biomedical Technologies2024-01-26
TITAN 3-D Wedge System (K231496)Paragon 28, Inc.2023-08-22
Trigon™ HA Stand-Alone Wedge Fixation System (K223226)Nvision Biomedical Technologies, Inc.2022-12-01
Trigon HA Wedge Fixation System (K220197)Nvision Biomedical Technologies, Inc.2022-02-23
Restor3d Utility Wedge (K201314)Restor3D, Inc.2021-06-17
Trigon HA Stand-Alone Wedge Fixation System (K203445)Nvision Biomedical Technologies, Inc.2020-12-21
Trigon HA Stand-Alone Wedge Fixation System (K193414)Nvision Biomedical Technologies, Inc.2020-02-25
Trigon™ Ti Stand-Alone Wedge Fixation System (K192645)Nvision Biomedical Technologies, Inc.2019-12-23
ADI TiDAL Osteotomy Wedge (K191047)Additive Device, Inc. (Adi) D/B/A Restor3D2019-11-05
Tyber Medical Wedge System (K171327)Tyber Medical, LLC2017-05-16
TITAN 3-D™ Wedge System (K162241)Paragon 282017-04-03
Arthrex BioSync® Bone Wedge (K151256)Arthex, Inc.2015-08-12
Tyber Medical Wedge System (K150394)Tyber Medical, LLC2015-07-28

Track PLF automatically

Every clearance here is in the API, with alerts when new ones post.