FDA.report

Elbow radius prosthesis

Definition
A sterile implantable device designed to replace the proximal radius typically as treatment for severe radial head fracture or degenerative disease (arthritis). The device includes a radial head or radial head with stem and is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] or metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.
GUDID devices
665
Last updated
2025-01-10 15:06:20

Related Product Codes

CodeDeviceSpecialtyClassDevices
KWIProsthesis, Elbow, Hemi-, Radial, PolymerOrthopedic2588
JDBProsthesis, Elbow, Semi-Constrained, CementedOrthopedic258
JDCProsthesis, Elbow, Constrained, CementedOrthopedic227
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerOrthopedic23

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00850005618034BioPoly® Radial Head ImplantBiopoly, LLC160-50602025-01-02
00850005618041BioPoly® Radial Head ImplantBiopoly, LLC160-50632025-01-02
00850005618058BioPoly® Radial Head ImplantBiopoly, LLC160-50662025-01-02
00850005618065BioPoly® Radial Head ImplantBiopoly, LLC160-50702025-01-02
00850005618072BioPoly® Radial Head ImplantBiopoly, LLC160-50732025-01-02
00850005618089BioPoly® Radial Head ImplantBiopoly, LLC160-50762025-01-02
00850005618249BioPoly® Radial Head ImplantBiopoly, LLC160-50802025-01-02
00850005618256BioPoly® Radial Head ImplantBiopoly, LLC160-50832025-01-02
00850005618263BioPoly® Radial Head ImplantBiopoly, LLC160-50862025-01-02
00850005618287BioPoly® Radial Head ImplantBiopoly, LLC160-53602025-01-02
00850005618294BioPoly® Radial Head ImplantBiopoly, LLC160-53632025-01-02
00850005618461BioPoly® Radial Head ImplantBiopoly, LLC160-53662025-01-02
00850005618478BioPoly® Radial Head ImplantBiopoly, LLC160-53702025-01-02
00850005618485BioPoly® Radial Head ImplantBiopoly, LLC160-53732025-01-02
00850005618492BioPoly® Radial Head ImplantBiopoly, LLC160-53762025-01-02
00850005618508BioPoly® Radial Head ImplantBiopoly, LLC160-53802025-01-02
00850005618522BioPoly® Radial Head ImplantBiopoly, LLC160-53832025-01-02
00850005618539 BioPoly® Radial Head ImplantBiopoly, LLC160-53862025-01-02
00850005618546BioPoly® Radial Head ImplantBiopoly, LLC160-53902025-01-02
00850005618553BioPoly® Radial Head ImplantBiopoly, LLC160-53932025-01-02
00850005618560BioPoly® Radial Head ImplantBiopoly, LLC160-53962025-01-02
00850005618577BioPoly® Radial Head ImplantBiopoly, LLC160-56702025-01-02
00850005618584BioPoly® Radial Head ImplantBiopoly, LLC160-56732025-01-02
00850005618591BioPoly® Radial Head ImplantBiopoly, LLC160-56762025-01-02
00850005618607BioPoly® Radial Head ImplantBiopoly, LLC160-56802025-01-02
00850005618614BioPoly® Radial Head ImplantBiopoly, LLC160-56832025-01-02
00850005618621BioPoly® Radial Head ImplantBiopoly, LLC160-56862025-01-02
00850005618638BioPoly® Radial Head ImplantBiopoly, LLC160-56902025-01-02
00850005618645BioPoly® Radial Head ImplantBiopoly, LLC160-56932025-01-02
00850005618652BioPoly® Radial Head ImplantBiopoly, LLC160-56962025-01-02
00885556827468Katalyst Biopolar Radial Head SystemSmith & Nephew, Inc.2259182023-01-19
00885556827475Katalyst Biopolar Radial Head SystemSmith & Nephew, Inc.2259212023-01-19
00885556827482Katalyst Biopolar Radial Head SystemSmith & Nephew, Inc.2259242023-01-19
00841506131542AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Head & Lock Screw, 28mm2023-08-11
00841506131566AlignSKELETAL DYNAMICS L.L.C.Trial, Radial Head, 28mm2023-08-11
00841506131573AlignSKELETAL DYNAMICS L.L.C.Trial, Radial Stem, 12.0mm2023-08-11
00841506131580AlignSKELETAL DYNAMICS L.L.C.Radial Planer, Stem 12.0mm2023-08-11
00841506131597AlignSKELETAL DYNAMICS L.L.C.Radial Rasp, Stem 12.0mm2023-08-11
00841506131603AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Stem, 12mm x 0mm2023-08-11
00841506131610AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Stem, 12mm x 2mm2023-08-11
00841506131627AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Stem, 12mm x 4mm2023-08-11
00841506131634AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Stem, 12mm x 6mm2023-08-11
00841506131641AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Stem, 12mm x 8mm2023-08-11
00841506131702AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Stem, 6mm x 0mm2023-08-11
00841506131719AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Stem, 6mm x 2mm2023-08-11
00841506131726AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Stem, 6mm x 4mm2023-08-11
00841506131733AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Stem, 6mm x 6mm2023-08-11
00841506131740AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Stem, 6mm x 8mm2023-08-11
00841506131757AlignSKELETAL DYNAMICS L.L.C.Radial Rasp, Stem 6.0mm2023-08-11
00841506131764AlignSKELETAL DYNAMICS L.L.C.Trial, Radial Stem, 6.0mm2023-08-11
00841506134192AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Stem, Long Trial 11.0mm2023-08-11
00841506132884AlignSKELETAL DYNAMICS L.L.C.ALIGN, Radial Universal Planar2023-08-11
00841506134130AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Head Large Sizer Tray2023-08-11
00841506134147AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Stem, Long Trial 6.0mm2023-08-11
00841506134154AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Stem, Long Trial 7.0mm2023-08-11
00841506134161AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Stem, Long Trial 8.0mm2023-08-11
00841506134178AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Stem, Long Trial 9.0mm2023-08-11
00841506134185AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Stem, Long Trial 10.0mm2023-08-11
00841506134208AlignSKELETAL DYNAMICS L.L.C.ALIGN Radial Stem, Long Trial 12.0mm2023-08-11
00885556827307Katalyst Bipolar Radial Head SystemSmith & Nephew, Inc.2214182022-12-21
00885556827314Katalyst Bipolar Radial Head SystemSmith & Nephew, Inc.2214212022-12-21
00885556827321Katalyst Biopolar Radial Head SystemSmith & Nephew, Inc.2214242022-12-21
00885556827338Katalyst Biopolar Radial Head SystemSmith & Nephew, Inc.2216652022-12-21
00885556827345Katalyst Biopolar Radial Head SystemSmith & Nephew, Inc.2216752022-12-21
00885556827352Katalyst Biopolar Radial Head SystemSmith & Nephew, Inc.2218002022-12-21
00885556857359Modular Radial Head (MRH) SystemSmith & Nephew, Inc.MRH-350-01-WW2022-12-22
00885556857366Modular Radial Head (MRH) SystemSmith & Nephew, Inc.MRH-350-02-WW2022-12-22
00885556857373Modular Radial Head (MRH) SystemSmith & Nephew, Inc.MRH-350-03-WW2022-12-22
00885556857380Modular Radial Head (MRH) SystemSmith & Nephew, Inc.MRH-350-04-WW2022-12-22
00885556857397Modular Radial Head (MRH) SystemSmith & Nephew, Inc.MRH-350-20L-WW2022-12-22
00885556857403Modular Radial Head (MRH) SystemSmith & Nephew, Inc.MRH-350-20S-WW2022-12-22
00885556857410Modular Radial Head (MRH) SystemSmith & Nephew, Inc.MRH-350-22L-WW2022-12-22
00885556857427Modular Radial Head (MRH) SystemSmith & Nephew, Inc.MRH-350-22S-WW2022-12-22
00885556857434Modular Radial Head (MRH) SystemSmith & Nephew, Inc.MRH-350-24L-WW2022-12-22
00885556857441Modular Radial Head (MRH) SystemSmith & Nephew, Inc.MRH-350-24S-WW2022-12-22
B033KCHI18090Seitz Solution Radial Head Implant System 18 x 9mm Radial HeadKapp Surgical Instrument Co.KCHI-18092023-06-09
B033KCHI18110Seitz Solution Radial Head Implant System 18 x 11mm Radial HeadKapp Surgical Instrument Co.KCHI-18112023-06-09
07612334207975NASynthes GmbH09.405.250S2020-06-08
07612334207982NASynthes GmbH09.405.253S2020-06-08
07612334207999NASynthes GmbH09.405.256S2020-06-08