ClearanceBrief
Panels › Orthopedic › Product code JDR · Class 2

Staple, Fixation, Bone

Regulation 888.3030

2510(k)s in 12 months (233 all time)
2recalls in 12 months (37 all time)
35recalls that name a 510(k)
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Top companies in JDR

Company510(k)sRecalls
Mitek Surgical Products, Inc.160
Smith & Nephew Inc., Endoscopy Division29
Acufex Microsurgical, Inc.90
Biomet, Inc.36
Depuy Mitek, A Johnson & Johnson Company71
Synthes (USA) Products, LLC25
Arthrex, Inc.60
Biomedical Ent., Inc.60
In2bones Sas42
Howmedica Corp.50
Decided510(k)Device and applicantCode
Sep 1, 2026K262451Arthrex DynaNite Staples
Arthrex, Inc.
JDR
Aug 6, 2026K261121Megalodon Dynamic Compression System
Paragon 28, Inc.
JDR
May 14, 2025K250712Linkt Compression Staple System
Trax Surgical
JDR
Apr 11, 2025K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant System
Medline Industries, LP
JDR
Jan 31, 2025K243742Arthrex DynaNite Nitinol Staples
Arthrex, Inc.
JDR
Dec 26, 2024K243658TMC Compression Implant System
Treace Medical Concepts
JDR
Sep 6, 2024K242415TMC Compression Implant System
Treace Medical Concepts
JDR
Feb 23, 2024K240212COGNiTiON™ Staple System
Ortho Solutions UK , Ltd., GB
JDR
Jan 12, 2024K232990A’TOMIC™ Nitinol Fixation System
Rmr Ortho, LLC
JDR
Dec 4, 2023K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staples
Novastep, FR
JDR
Oct 19, 2023K232905Medline UNITE® REFLEX® Nitinol Staple Kit
Medline Industries, LP
JDR
Aug 30, 2023K232324StealthFix Intraosseous Fixation System
Medartis, Inc.
JDR
Aug 28, 2023K232387Treace Medical Concepts (TMC) Compression Implant System
Treace Medical Concepts
JDR
Aug 11, 2023K231493NITINEX Memory Compression Staple
Vilex, LLC
JDR
Aug 9, 2023K231885Medline UNITE® REFLEX® Nitinol Staple System
Medline Industries, LP
JDR
Aug 3, 2023K231458Extremity Staple
Restor3D
JDR
May 11, 2023K230550JAWS Nitinol Staple System
Paragon 28, Inc.
JDR
Feb 16, 2023K223056JAWS Nitinol Staple System
Paragon 28, Inc.
JDR
Nov 21, 2022K222645Treace Medical Concepts (TMC) Implant Fixation System
Treace Medical Concepts
JDR
Oct 20, 2022K221947Tyber Medical Staple Fixation System (various)
Tyber Medical, LLC
JDR
Aug 19, 2022K220812DynaClip® Bone Staple
MedShape, Inc.
JDR
Jun 10, 2022K210582EasyClip® and EasyClip® Xpress
Stryker GmbH
JDR
Mar 22, 2022K220181StealthFix Intraosseous Fixation System
Nextremity Solutions, Inc.
JDR
May 7, 2021K203832FuseForce™ Flex Dynamic Compression System
Wright Medical
JDR
Apr 22, 2021K210482Medline UNITE REFLEX Nitinol Staple System
Medline Industries, Inc.
JDR
Apr 12, 2021K210456Ligament Staple
Medacta International S.A., CH
JDR
Dec 16, 2020K203180Arthrex DynaNite Nitinol Staples
Arthrex, Inc.
JDR
Apr 23, 2020K193305DynaClip Bone Staple
MedShape, Inc.
JDR
Feb 28, 2020K192447Superelastic Staple
Neosteo, FR
JDR
Feb 26, 2020K191463DePuy Synthes Hammertoe Continuous Compression Implant
Synthes (USA) Products, LLC
JDR
Aug 16, 2019K191636APTUS Foot System
Medartis AG, CH
JDR
Aug 16, 2019K190722TriMAX Implant System
Crossroads Extemity Systems, LLC
JDR
Jul 1, 2019K190166TriMed Nitinol Staple System
TriMed, Inc.
JDR
Apr 4, 2019K182943VERTEX Nitinol Staple System
Nvision Biomedical Technologies, LLC
JDR
Jan 11, 2019K182212Geo Staple System
Gramercy Extremity Orthopedics, LLC
JDR
Nov 5, 2018K181781DynaClipTM Bone Staple
MedShape, Inc.
JDR
Oct 15, 2018K181815DynaBridge
Fusion Orthopedics, LLC
JDR
Aug 9, 2018K181866MotoCLIP/HiMAX Step Staple Implant System
Crossroads Extremity Systems, LLC
JDR
Jul 24, 2018K180544DePuy Synthes Static Staples
Synthes (USA) Products, LLC
JDR
Jun 29, 2018K181410MotoCLIP/HiMAX Implant System
Crossroads Extremity Systems, LLC
JDR
Apr 6, 2018K173775Clench Compression Staple
F & A Foundation, LLC D.B.A. Reign Medical
JDR
Feb 23, 2018K173693Orbitum Bone Staple Implant, X and VI
Orthovestments, LLC
JDR
Jan 11, 2018K172205ExoToe Staple
Exotoe, LLC
JDR
Dec 13, 2017K172052Arthrex DynaNite Nitinol Staple
Arthrex, Inc.
JDR
Dec 11, 2017K172405SNIPER STAPLE SYSTEM, NON-STERILE
Trilliant Surgical
JDR
Nov 7, 2017K171473Compressyn™ Staple
Dallen Medical, Inc.
JDR
Jul 24, 2017K170923JAWS(TM) Nitinol Staple System
Paragon 28
JDR
May 16, 2017K163226EPIC Extremely Small Staple
Epic Extremely, LLC
JDR
Apr 20, 2017K162354Sniper Staple System
Trilliant Surgical, Ltd.
JDR
Feb 10, 2017K162321EasyClip Xpress
Restore Surgical, LLC Dba Instratek
JDR

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