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Bone Wedge

FDA product code PLF · Class 2 · Orthopedic

404
Registered devices
25
Adverse events
9
Recalls
18
510(k) clearances

Devices with this code

ARKEO, Wedge Fixation System — Auxano Medical LLCTrigon — NVision Biomedical Technologies, Inc.Foot Osteotomy Wedge System — Tyber Medical, LLCrestor3d Utility Wedge — Restor3d, Inc.restor3d Utility Wedge — Restor3d, Inc.restor3d Utility Wedge — Restor3d, Inc.APTUS — Medartis AGRIPTIDE — Tyber Medical, LLCSiNAPTIC Osteotomy Wedge System — SINTX Technologies, Inc.SiNAPTIC Osteotomy Wedge System — SINTX Technologies, Inc.Foot Osteotomy Wedge System — Tyber Medical, LLCrestor3d Osteotomy Wedge — Restor3d, Inc.restor3d Utility Wedge — Restor3d, Inc.RIPTIDE — Tyber Medical, LLCrestor3d Osteotomy Wedge — Restor3d, Inc.SiNAPTIC Osteotomy Wedge System — SINTX Technologies, Inc.Trigon — NVision Biomedical Technologies, Inc.P-tanium Wedge — Tyber Medical, LLCRIPTIDE — Tyber Medical, LLCTrigon — NVision Biomedical Technologies, Inc.LapiLock — FUSION ORTHOPEDICS, LLCrestor3d Osteotomy Wedge — Restor3d, Inc.ARKEO, Wedge Fixation System — Auxano Medical LLCRIPTIDE — Tyber Medical, LLC

Recent recalls

DateFirmReason
2026-07-10Paragon 28, Inc.Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
2026-07-10Paragon 28, Inc.Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
2018-09-28Paragon 28, Inc.It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a
2016-04-22Arthrex, Inc.Potential for polystyrene particulate presence.
2016-04-22Arthrex, Inc.Potential for polystyrene particulate presence.
2016-04-22Arthrex, Inc.Potential for polystyrene particulate presence.
2016-04-22Arthrex, Inc.Potential for polystyrene particulate presence.
2016-04-22Arthrex, Inc.Potential for polystyrene particulate presence.
2016-04-22Arthrex, Inc.Potential for polystyrene particulate presence.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.