Bone Wedge
Orthopedic · 21 CFR 888.3030
Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
Recent MDR events
23 adverse event reports on file
- PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANTJun 29, 2026Injury4web, Inc.3009189869-2026-00011
- PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANTMar 26, 2026Injury4web, Inc.3009189869-2026-00006
- PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANTFeb 24, 2026Injury4web, Inc.3009189869-2026-00001
- PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANTDec 11, 2025Injury4web, Inc.3009189869-2025-00011
- RESTOR3DFeb 19, 2025MalfunctionRestor3d, Inc.21409805
- PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANTDec 10, 2024Injury4web, Inc.3009189869-2024-00019
- PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANTAug 26, 2024Injury4web, Inc.3009189869-2024-00013
- PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANTFeb 26, 2024Injury4web, Inc.3009189869-2024-00004
- PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANTJun 21, 2023Injury4web, Inc.3009189869-2023-00006
- PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANTMay 4, 2023Injury4web, Inc.3009189869-2023-00005
Event type breakdown
Most-reported manufacturers
Recalls
9 recall events for this product code
- Paragon 28, Inc.Open, ClassifiedAug 14, 2026
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Z-2971-2026 · View FDA record ↗ - Paragon 28, Inc.Open, ClassifiedAug 14, 2026
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Z-2972-2026 · View FDA record ↗ - Paragon 28, Inc.TerminatedDec 10, 2019
P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only
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 12mm size. Use of the product could result in improper preparation of the surgical site causing delays in surgery.
Z-0662-2020 · View FDA record ↗ - Arthrex, Inc.TerminatedUnknown
BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Potential for polystyrene particulate presence.
Z-1958-2016 · View FDA record ↗ - Arthrex, Inc.TerminatedUnknown
BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Potential for polystyrene particulate presence.
Z-1959-2016 · View FDA record ↗ - Arthrex, Inc.TerminatedUnknown
BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Potential for polystyrene particulate presence.
Z-1960-2016 · View FDA record ↗ - Arthrex, Inc.TerminatedUnknown
BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Potential for polystyrene particulate presence.
Z-1961-2016 · View FDA record ↗ - Arthrex, Inc.TerminatedUnknown
BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Potential for polystyrene particulate presence.
Z-1962-2016 · View FDA record ↗ - Arthrex, Inc.TerminatedUnknown
BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Potential for polystyrene particulate presence.
Z-1963-2016 · View FDA record ↗
Registered firms
51 firms currently registered for this product code
Auxano Medical Llc
Brecksville, OH, US
Paragon 28
Englewood, CO, US
Tribe Medical Group
London Ontario, CA
Tangible Solutions, Inc. Dba Marle Tangible, Inc.
Fairborn, OH, US
Sites Medical, Llc
Columbia City, IN, US
Arthrex Singapore Pte Ltd.
Singapore Central Singapore, SG
Arthrex Manufacturing Inc.
Pendleton, SC, US
Isomedix Operations Inc.
Sandy, UT, US
Ames Medical Prosthetic Solutions, S.a.u.
St. Feliu del Llobregat Barcelona, ES
Arthrex New Zealand Limited
Auckland, NZ
Nvision Biomedical Technologies, Inc
San Antonio, TX, US
Arthrex, Inc.
Naples, FL, US
Sterigenics Us, Llc
Lewis Center, OH, US
Hnm Medical Dba Hnm Total Recon
Miami, FL, US
Biopro, Inc.
PORT HURON, MI, US
Medartis Inc.
Warsaw, IN, US
Bioseal
PLACENTIA, CA, US
Tyber Medical
Bethlehem, PA, US
Tyber Medical
Bethlehem, PA, US
Medartis Ag
BASEL Basel-Stadt, CH
510(k) clearances
18 clearances for this product code
- MiRus, LLCFeb 19, 2026
K252733 · ATLAS Expandable Osteotomy Wedge System
- Sinaptic SurgicalOct 17, 2025
K252254 · Osteotomy Wedge System
- Auxano Medical, LLCSep 25, 2025
K251791 · Auxano® Wedge Fixation System
- Ames Medical Prosthetic Solutions, S.A.U.Dec 6, 2024
K240461 · OsteoSinter® EVANS and COTTON wedges and related accessories
- Nvision Biomedical TechnologiesNov 8, 2024
K243231 · Trigon PEEK HA Wedges
- Nvision Biomedical TechnologiesJan 26, 2024
K234116 · Trigon Trigon HA Stand-Alone Wedge Fixation System
- Paragon 28, Inc.Aug 22, 2023
K231496 · TITAN 3-D Wedge System
- Nvision Biomedical Technologies, Inc.Dec 1, 2022
K223226 · Trigon HA Stand-Alone Wedge Fixation System