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Bone Wedge
FDA product code PLF · Class 2 · Orthopedic
404
Registered devices
23
Adverse events
9
Recalls
18
510(k) clearances
Devices with this code
ARKEO, Wedge Fixation System — Auxano Medical LLCRIPTIDE — Tyber Medical, LLCrestor3d Utility Wedge — Restor3d, Inc.ARKEO, Wedge Fixation System — Auxano Medical LLCTrigon — NVISION BIOMEDICAL TECHNOLOGIES, INC.Trigon — NVISION BIOMEDICAL TECHNOLOGIES, INC.TITAN 3-D Wedge System — Paragon 28, Inc.P-tanium Wedge — Tyber Medical, LLCTrigon — NVISION BIOMEDICAL TECHNOLOGIES, INC.APTUS — Medartis AGOsteoSinter® COTTON wedge 20L x 6.5H mm — AMES MEDICAL PROSTHETIC SOLUTIONS S.A.APTUS — Medartis AGTrigon — NVISION BIOMEDICAL TECHNOLOGIES, INC.TITAN 3-D Wedge System — Paragon 28, Inc.RIPTIDE — Tyber Medical, LLCARKEO, Wedge Fixation System — Auxano Medical LLCrestor3d Osteotomy Wedge — Restor3d, Inc.P-tanium Wedge — Tyber Medical, LLCRIPTIDE — Tyber Medical, LLCTrigon — NVISION BIOMEDICAL TECHNOLOGIES, INC.RIPTIDE — Tyber Medical, LLCOsteoSinter® EVANS wedge 20W x 20L x 10H mm — AMES MEDICAL PROSTHETIC SOLUTIONS S.A.P-tanium Wedge — Tyber Medical, LLCrestor3d Osteotomy Wedge — Restor3d, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-10 | Paragon 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. |
| 2026-07-10 | Paragon 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. |
| 2018-09-28 | Paragon 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 |
| 2016-04-22 | Arthrex, Inc. | Potential for polystyrene particulate presence. |
| 2016-04-22 | Arthrex, Inc. | Potential for polystyrene particulate presence. |
| 2016-04-22 | Arthrex, Inc. | Potential for polystyrene particulate presence. |
| 2016-04-22 | Arthrex, Inc. | Potential for polystyrene particulate presence. |
| 2016-04-22 | Arthrex, Inc. | Potential for polystyrene particulate presence. |
| 2016-04-22 | Arthrex, Inc. | Potential for polystyrene particulate presence. |
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