FDA.reportPublic FDA data

Orthopaedic bone staple, non-adjustable

Definition
A non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.
GUDID devices
566
Last updated
2026-10-04 01:44:16

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04546540148759XIA IIStryker Corporation038201042014-12-08
04546540218896XIA STAINLESS STEELStryker Corporation482201042014-12-08
04546540377302XIA IIStryker Corporation038201102014-12-08
04546540377319XIA IIStryker Corporation038201112014-12-08
04546540377326XIA IIStryker Corporation038201122014-12-08
04546540377333XIA IIStryker Corporation038201132014-12-08
04546540377340XIA IIStryker Corporation038201142014-12-08
04546540377357XIA IIStryker Corporation038201152014-12-08
04546540448910XIA 4 5Stryker Corporation481301102014-12-08
04546540448927XIA 4 5Stryker Corporation481301112014-12-08
04546540448934XIA 4 5Stryker Corporation481301122014-12-08
04546540448941XIA 4 5Stryker Corporation481301132014-12-08
07613153143581XIA STAINLESS STEELStryker Corporation482201102014-12-08
07613153143598XIA STAINLESS STEELStryker Corporation482201112014-12-08
07613153143604XIA STAINLESS STEELStryker Corporation482201122014-12-08
07613153143611XIA STAINLESS STEELStryker Corporation482201132014-12-08
07613153143628XIA STAINLESS STEELStryker Corporation482201142014-12-08
07613153143635XIA STAINLESS STEELStryker Corporation482201152014-12-08
10888857025110ARI™ Anterior Staple SystemVB Spine LLC1801-D15152015-09-24
10888857025127ARI™ Anterior Staple SystemVB Spine LLC1801-D1515-SG2016-11-14
10888857025134ARI™ Anterior Staple SystemVB Spine LLC1801-D2413L2015-09-24
10888857025141ARI™ Anterior Staple SystemVB Spine LLC1801-D2413R2015-09-24
10888857025158ARI™ Anterior Staple SystemVB Spine LLC1801-D2416L2015-09-24
10888857025165ARI™ Anterior Staple SystemVB Spine LLC1801-D2416R2015-09-24
10888857025172ARI™ Anterior Staple SystemVB Spine LLC1801-D2418L2015-09-24
10888857025189ARI™ Anterior Staple SystemVB Spine LLC1801-D2418R2015-09-24
00888867574342Arthrex®ARTHREX, INC.AR-8719MX4DS-35202026-09-18
00888867574359Arthrex®ARTHREX, INC.AR-8719MX4DS-30202026-09-18
00888867574366Arthrex®ARTHREX, INC.AR-8719MX4DS-25182026-09-18
00888867574373Arthrex®ARTHREX, INC.AR-8719W5DS-15152026-09-18
00888867574380Arthrex®ARTHREX, INC.AR-8719W5DS-18182026-09-18
00888867574397Arthrex®ARTHREX, INC.AR-8719W5DS-20202026-09-18
00888867574403Arthrex®ARTHREX, INC.AR-8719W5DS-25202026-09-18
00888867574410Arthrex®ARTHREX, INC.AR-8719W6DS-20202026-09-18
00888867574427Arthrex®ARTHREX, INC.AR-8719W6DS-25202026-09-18
00888867574434Arthrex®ARTHREX, INC.AR-8719MXR-12026-09-18
00888867574441Arthrex®ARTHREX, INC.AR-8719R-12026-09-18
00888867574458Arthrex®ARTHREX, INC.AR-8719MXRDS2026-09-18
00888867574465Arthrex®ARTHREX, INC.AR-8719RDS2026-09-18
00888867574595Arthrex®ARTHREX, INC.AR-8719MXR-22026-09-18
00888867574601Arthrex®ARTHREX, INC.AR-8719R-22026-09-18
00810005661010VertexNVision Biomedical Technologies, Inc.STK-08-08-082020-12-28
00810005661027VertexNVision Biomedical Technologies, Inc.STK-10-10-102020-12-28
00810005661034VertexNVision Biomedical Technologies, Inc.STK-12-12-122020-12-28
00810005661041VertexNVision Biomedical Technologies, Inc.STK-14-14-142020-12-28
00810005661058VertexNVision Biomedical Technologies, Inc.STK-16-14-142020-12-28
00810005661065VertexNVision Biomedical Technologies, Inc.STK-16-16-162020-12-28
00810005661072VertexNVision Biomedical Technologies, Inc.STK-18-14-142020-12-28
00810005661089VertexNVision Biomedical Technologies, Inc.STK-18-18-182020-12-28
00810005661096VertexNVision Biomedical Technologies, Inc.STK-20-14-142020-12-28
00810005665155VertexNVision Biomedical Technologies, Inc.STK-20-18-182020-12-28
00810005665162VertexNVision Biomedical Technologies, Inc.STK-20-20-202020-12-28
00810135964180VertexNVision Biomedical Technologies, Inc.STK-20-16-162025-12-17
00860005968824RELJA Innovations Nitinol Staple Kit 15mmx12mmRelja Innovations LLCRI-NS-152025-09-19
00860005968831RELJA Innovations Nitinol Staple Kit 18x18Relja Innovations LLCRI-NS-182025-09-19
00888867042377Arthrex®ARTHREX, INC.AR-8004-15S2017-02-15
00810111224062TMC SpeedMTPTreace Medical Concepts, Inc.NK292026-03-30
00810111227223SpeedMTP SelectTreace Medical Concepts, Inc.SK692026-05-13
00810111227247SpeedMTP SelectTreace Medical Concepts, Inc.SD342026-05-13
00810111227254SpeedMTP SelectTreace Medical Concepts, Inc.SD332026-05-13
00854325007196RELJA Innovations Nitinol Staple Kit 15mm x 12mmF & A Foundation LLCRI-NS-152026-04-10
00854325007202RELJA Innovations Nitinol Staple Kit 18mm x 18mmF & A Foundation LLCRI-NS-182026-04-10
00860012784707Toetal Implant, Packaged, 3mm, 16mmToetal Solutions IncT-60-0002-012026-04-02
00860012784714Toetal Implant, Packaged, 3mm, 18mmToetal Solutions IncT-60-0002-022026-04-02
00860012784721Toetal Implant, Packaged, 3mm, 20mmToetal Solutions IncT-60-0002-032026-04-02
00860012784738Toetal Implant, Packaged, 3mm, 22mmToetal Solutions IncT-60-0002-042026-04-02
00860012784745Toetal Implant, Packaged, 3mm, 24mmToetal Solutions IncT-60-0002-052026-04-02
07630037889397APTUSMedartis AGA-4090.04S2023-03-03
10381780052364SOLUSTAPLENEWDEAL114002ND2017-10-09
10381780052388SOLUSTAPLENEWDEAL114004ND2017-10-09
10381780052401SOLUSTAPLENEWDEAL114023ND2017-10-09
10381780052425SOLUSTAPLENEWDEAL114025ND2017-10-09
10381780052449UNI-CLIPNEWDEAL213113ND2017-10-09
10381780052463UNI-CLIPNEWDEAL213114ND2017-10-09
10381780052487UNI-CLIPNEWDEAL213115ND2017-10-09
10381780052500UNI-CLIPNEWDEAL213116ND2017-10-09
10381780052548UNI-CLIPNEWDEAL213213ND2017-10-09
10381780052562UNI-CLIPNEWDEAL213214ND2017-10-09
10381780052586UNI-CLIPNEWDEAL213215ND2017-10-09
10381780052647UNI-CLIPNEWDEAL213313ND2017-10-09