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Staple, Fixation, Bone

FDA product code JDR · 215 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3030
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-12-05 – 2026-09-01

JDR 2026-09-01

Arthrex DynaNite Staples

Applicant Arthrex, Inc.

K number K262451

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JDR 2026-08-06

Megalodon Dynamic Compression System

Applicant Paragon 28, Inc.

K number K261121

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JDR 2025-05-14

Linkt Compression Staple System

Applicant Trax Surgical

K number K250712

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JDR 2025-04-11

Medline UNITE® REFLEX® Hybrid Nitinol Implant System

Applicant Medline Industries, LP

K number K243888

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JDR 2025-01-31

Arthrex DynaNite Nitinol Staples

Applicant Arthrex, Inc.

K number K243742

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JDR 2024-12-26

TMC Compression Implant System

Applicant Treace Medical Concepts

K number K243658

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JDR 2024-09-06

TMC Compression Implant System

Applicant Treace Medical Concepts

K number K242415

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JDR 2024-02-23

COGNiTiON™ Staple System

Applicant Ortho Solutions UK , Ltd.

K number K240212

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JDR 2024-01-12

A’TOMIC™ Nitinol Fixation System

Applicant Rmr Ortho, LLC

K number K232990

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JDR 2023-12-04

arcad® 2.0 Duo & Quadro osteosynthesis compressive staples

Applicant Novastep

K number K230724

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JDR 2023-10-19

Medline UNITE® REFLEX® Nitinol Staple Kit

Applicant Medline Industries, LP

K number K232905

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JDR 2023-08-30

StealthFix Intraosseous Fixation System

Applicant Medartis, Inc.

K number K232324

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JDR 2023-08-28

Treace Medical Concepts (TMC) Compression Implant System

Applicant Treace Medical Concepts

K number K232387

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JDR 2023-08-11

NITINEX Memory Compression Staple

Applicant Vilex, LLC

K number K231493

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JDR 2023-08-09

Medline UNITE® REFLEX® Nitinol Staple System

Applicant Medline Industries, LP

K number K231885

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JDR 2023-08-03

Extremity Staple

Applicant Restor3D

K number K231458

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JDR 2023-05-11

JAWS Nitinol Staple System

Applicant Paragon 28, Inc.

K number K230550

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JDR 2023-02-16

JAWS Nitinol Staple System

Applicant Paragon 28, Inc.

K number K223056

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JDR 2022-11-21

Treace Medical Concepts (TMC) Implant Fixation System

Applicant Treace Medical Concepts

K number K222645

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JDR 2022-10-20

Tyber Medical Staple Fixation System (various)

Applicant Tyber Medical, LLC

K number K221947

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JDR 2022-08-19

DynaClip® Bone Staple

Applicant MedShape, Inc.

K number K220812

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JDR 2022-06-10

EasyClip® and EasyClip® Xpress

Applicant Stryker GmbH

K number K210582

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JDR 2022-03-22

StealthFix Intraosseous Fixation System

Applicant Nextremity Solutions, Inc.

K number K220181

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JDR 2021-05-07

FuseForce™ Flex Dynamic Compression System

Applicant Wright Medical

K number K203832

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JDR 2021-04-22

Medline UNITE REFLEX Nitinol Staple System

Applicant Medline Industries, Inc.

K number K210482

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JDR 2021-04-12

Ligament Staple

Applicant Medacta International S.A.

K number K210456

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JDR 2020-12-16

Arthrex DynaNite Nitinol Staples

Applicant Arthrex, Inc.

K number K203180

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JDR 2020-04-23

DynaClip Bone Staple

Applicant MedShape, Inc.

K number K193305

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JDR 2020-02-28

Superelastic Staple

Applicant Neosteo

K number K192447

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JDR 2020-02-26

DePuy Synthes Hammertoe Continuous Compression Implant

Applicant Synthes (USA) Products, LLC

K number K191463

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JDR 2019-08-16

APTUS Foot System

Applicant Medartis AG

K number K191636

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JDR 2019-08-16

TriMAX Implant System

Applicant Crossroads Extemity Systems, LLC

K number K190722

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JDR 2019-07-01

TriMed Nitinol Staple System

Applicant TriMed, Inc.

K number K190166

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JDR 2019-04-04

VERTEX Nitinol Staple System

Applicant Nvision Biomedical Technologies, LLC

K number K182943

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JDR 2019-01-11

Geo Staple System

Applicant Gramercy Extremity Orthopedics, LLC

K number K182212

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JDR 2018-11-05

DynaClipTM Bone Staple

Applicant MedShape, Inc.

K number K181781

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JDR 2018-10-15

DynaBridge

Applicant Fusion Orthopedics, LLC

K number K181815

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JDR 2018-08-09

MotoCLIP/HiMAX Step Staple Implant System

Applicant Crossroads Extremity Systems, LLC

K number K181866

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JDR 2018-07-24

DePuy Synthes Static Staples

Applicant Synthes (USA) Products, LLC

K number K180544

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JDR 2018-06-29

MotoCLIP/HiMAX Implant System

Applicant Crossroads Extremity Systems, LLC

K number K181410

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JDR 2018-04-06

Clench Compression Staple

Applicant F & A Foundation, LLC D.B.A. Reign Medical

K number K173775

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JDR 2018-02-23

Orbitum Bone Staple Implant, X and VI

Applicant Orthovestments, LLC

K number K173693

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JDR 2018-01-11

ExoToe Staple

Applicant Exotoe, LLC

K number K172205

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JDR 2017-12-13

Arthrex DynaNite Nitinol Staple

Applicant Arthrex, Inc.

K number K172052

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JDR 2017-12-11

SNIPER STAPLE SYSTEM, NON-STERILE

Applicant Trilliant Surgical

K number K172405

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JDR 2017-11-07

Compressyn™ Staple

Applicant Dallen Medical, Inc.

K number K171473

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JDR 2017-07-24

JAWS(TM) Nitinol Staple System

Applicant Paragon 28

K number K170923

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JDR 2017-05-16

EPIC Extremely Small Staple

Applicant Epic Extremely, LLC

K number K163226

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JDR 2017-04-20

Sniper Staple System

Applicant Trilliant Surgical, Ltd.

K number K162354

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JDR 2017-02-10

EasyClip Xpress

Applicant Restore Surgical, LLC Dba Instratek

K number K162321

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JDR 2017-02-01

Stealth Staple System

Applicant First Ray, LLC

K number K163440

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JDR 2017-02-01

Memodyn Staple

Applicant Austin & Associates, Inc./Telos Medical Equipment

K number K161587

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JDR 2016-10-24

NeoSpan Compression Staple Impant w/instruments

Applicant In2bones USA, LLC

K number K161426

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JDR 2016-07-26

EasyStep

Applicant Stryker GmbH

K number K160813

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JDR 2016-04-08

First Ray Internal Bone Staple System

Applicant First Ray, LLC

K number K153622

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JDR 2016-03-21

OS2(R)-VP Varisation Staple

Applicant In2bones Sas

K number K153770

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JDR 2016-02-18

OS2-C Compression Staple

Applicant In2bones Sas

K number K153395

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JDR 2016-01-28

dynaMX Tabbed Staple

Applicant Mx Orthopedics, Corp.

K number K153129

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JDR 2013-12-30

COMPRESSYN STAPLE

Applicant Dallen Medical, Inc.

K number K132875

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JDR 2013-08-28

RESTORE BUNION CORRECTION SYSTEM

Applicant Nextremity Solutions

K number K131061

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JDR 2013-08-15

ORTHOHELIX STAPLE SYSTEM

Applicant Orthohelix Surgical Designs, Inc.

K number K130832

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JDR 2013-07-10

FUSEFORCE IMPLANT SYSTEM

Applicant Solana Surgical, LLC

K number K124045

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JDR 2013-05-14

SPEED SHIFT

Applicant Biomedical Enterprises, Inc.

K number K124022

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JDR 2013-05-03

METASURG NITINOL STAPLE IMPLANT

Applicant Metasurg

K number K123926

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JDR 2013-03-12

MEMORY METAL STAPLES, EASYCLIP

Applicant Stryker Corp.

K number K122113

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JDR 2013-02-07

COMPRESSYN STAPLE

Applicant Dallen Medical, Inc.

K number K122871

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JDR 2013-01-03

SUPER STAPLE(TM) CLASSIC

Applicant Metric Medical Devices, Inc.

K number K123363

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JDR 2012-10-09

VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)

Applicant Vilex, Inc.

K number K112837

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JDR 2011-10-24

MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES

Applicant Mediscope Manufacturing, Inc.

K number K102387

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JDR 2010-12-08

SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM

Applicant Suspension Orthopaedic Solutions, LLC

K number K102143

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JDR 2010-09-03

OSSTAPLE CHILL

Applicant Biomedical Ent., Inc.

K number K102107

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JDR 2008-11-03

OSTEORAPTOR SUTURE ANCHOR

Applicant Smith & Nephew Inc., Endoscopy Division

K number K082215

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JDR 2008-07-17

COMPOSITE HITCH SUTURE ANCHOR

Applicant Biomet Manufacturing Corp

K number K081172

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JDR 2008-07-16

ENDOBUTTON CONTINUOUS LOOP (CL)

Applicant Smith & Nephew Inc., Endoscopy Division

K number K081098

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JDR 2008-05-02

CAIS STAPLE

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K073281

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JDR 2008-02-13

ARTHREX COMPRESSION STAPLE

Applicant Arthrex, Inc.

K number K080111

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JDR 2007-10-29

BIOPRO MEMORY STAPLE, MODELS 18062-18073

Applicant Biopro, Inc.

K number K072298

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JDR 2007-08-15

REVERTO 55 AND 37 SHAPE MEMORY STAPLES

Applicant Core Essence Orthopaedics, LLC

K number K071477

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JDR 2007-08-03

INTRINSIC THERAPEUTICS FIXATION STAPLE

Applicant Intrinsic Therapeutics Incorporated

K number K071637

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JDR 2007-08-02

SBI STAFIX

Applicant Small Bone Innovations, Inc.

K number K071479

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JDR 2007-06-29

MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K071257

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JDR 2007-05-18

NEXFIX COMPRESSION STAPLE

Applicant Nexa Orthopedics, Inc.

K number K070688

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JDR 2007-03-19

MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10

Applicant Memometal Technologies

K number K070033

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JDR 2007-03-19

MEMOMETAL MEMORY STAPLES

Applicant Memometal Technologies

K number K070031

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JDR 2006-11-22

PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR

Applicant Depuy Miltek, A Johnson & Johnson Co.

K number K063273

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JDR 2006-11-22

ADJUST-RIGHT FIXATION DEVICES

Applicant Valpo Orthopedic Technology, Inc.

K number K062734

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JDR 2006-09-25

ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE

Applicant Arthrotek, Inc.

K number K061776

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JDR 2006-08-22

BIOKNOTLESS AND LUPINE PLUS ANCHORS

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K062170

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JDR 2006-08-21

BIOPRO MEMORY STAPLE

Applicant Biopro, Inc.

K number K061798

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JDR 2006-08-07

2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS

Applicant Arthrotek, Inc.

K number K061801

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JDR 2006-07-25

HITCH LACTOSORB SUTURE ANCHOR

Applicant Arthrotek, Inc.

K number K061657

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JDR 2006-07-19

ALLTHREAD LACTOSORB SUTURE ANCHOR

Applicant Arthrotek, Inc.

K number K061389

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JDR 2006-07-05

AXYALOOP NONABSORBABLE BONE ANCHOR

Applicant Axya Medical, Inc.

K number K060970

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JDR 2006-07-03

LARGE UNI-CLIP STAPLE

Applicant New Deal, S.A.

K number K061594

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JDR 2006-05-25

MEMORY STAPLE

Applicant DePuy Orthopaedics, Inc.

K number K060746

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JDR 2006-05-04

RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K060553

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JDR 2006-04-03

INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKS

Applicant Intelifuse, Inc.

K number K060014

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JDR 2005-10-21

SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K052631

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JDR 2005-08-05

GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K051989

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JDR 2005-06-29

INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS

Applicant Intelifuse, Inc.

K number K051408

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